MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Model Number G57454

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p200023.Investigation is still pending.A follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

User error: incorrect size access sheath used.Per email: i met with a physician who shared with me some images of a previous zilver vena placed that has now fractured.The patient returned, due to re-thrombosing and the doctor placed an additional stent in the proximal piece that was fractured.Two stents were placed that day and are listed below.Account: (b)(6).Original case date was 1/21/2022.12fr access sheath was used in the initial and replacement procedure related to (b)(4).This file will capture the use of a 12fr access sheath with the initial device.Patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? no.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? patient had another dvt.4.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? 6.Has the complainant reported that the product caused or contributed to the adverse effects? a.Please specify: adverse effects and provide details.Patient/event info - notes: the following information has been requested via email on 27 feb 2023.(b)(6) 27 feb 2023.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify:.Was a stent previously placed during previous procedures? was the device used percutaneously? where on the patient was the percutaneous access site? was the access site jugular or femoral? n/a, jugular, femoral other if other, please specify:.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify:.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.Was pre-dilation performed ahead of placement of the stent? what was the target location for the stent? details of access sheath used (name, fr size, length)? was the device flushed through both flushing ports before the procedure, as per ifu? details of the wire guide used (name, diameter, hyrdophyllic)? was resistance encountered when advancing the wire guide to the target location? was resistance encountered when advancing the delivery system to the target location? if resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? did the user pull the handle towards the hub during deployment, per ifu? did the user push the hub during deployment? did the user remove slack in the delivery system before deployment, per ifu? was the stent deployed smoothly / without resistance? was the stent fully deployed in the patient? was the stent fully deployed before removing the delivery system from the patient? was post dilation performed after the placement of the stent? was the delivery system damaged/kinked/twisted during deployment? what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure, or was it scheduled for another day? n/a, same procedure, another day.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? please specify: if yes.Per rep: i am trying to schedule a meeting with the doc to answer the unanswered questions, but (b)(6) is not an easy hospital to get access to.(b)(6) 02 mar 2023.7.Will the product be returned? no, still in the patient.8.Usage of product: a.Initial use of device; correct.B.Reuse of device.C.Unknown.9.Was product reprocessed for reuse prior to occurrence? 10.Did the product regarding this complaint come in contact with the patient? 11.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 12.What type of procedure was being performed? thrombectomy and venogram.13.Did the event result in a death? no.14.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.15.Was the patient hospitalized or was there prolonged hospitalization? 16.Did the patient require any additional procedures due to this occurrence? 17.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify: additional procedures and provide details.18.Has the complainant reported any adverse effects on the patient due to this occurrence? 19.Has the complainant reported that the product caused or contributed to the adverse effects? 20.Please specify: adverse effects and provide details? 21.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.A.If other, please specify:.22.Was a stent previously placed during previous procedures? 23.Was the device used percutaneously? 24.Where on the patient was the percutaneous access site? 25.Was the access site jugular or femoral? n/a, jugular, femoral other.A.If other, please specify:.26.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? a.If other, please specify:.27.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.28.Was pre-dilation performed ahead of placement of the stent? 29.What was the target location for the stent? 30.Details of access sheath used (name, fr size, length)? 31.Was the device flushed through both flushing ports before the procedure, as per ifu? 32.Details of the wire guide used (name, diameter, hyrdophyllic)? 33.Was resistance encountered when advancing the wire guide to the target location? 34.Was resistance encountered when advancing the delivery system to the target location? 35.If resistance was met, how did the physician address this? 36.Did the tip of the delivery system cross the target location? 37.Did the user pull the handle towards the hub during deployment, per ifu? 38.Did the user push the hub during deployment? 39.Did the user remove slack in the delivery system before deployment, per ifu? 40.Was the stent deployed smoothly / without resistance? 41.Was the stent fully deployed in the patient? 42.Was the stent fully deployed before removing the delivery system from the patient? 43.Was post dilation performed after the placement of the stent? 44.Was the delivery system damaged/kinked/twisted during deployment? 45.What intervention (if any) was required? 46.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day.47.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify: if yes.The following information has been requested via email by(b)(6) on 20 mar 2023.(b)(6) 20 mar 2023.1.Did both lot#: c1766826 & c1799437 fracture, or just one of them? we don¿t know which stent was placed proximally to identify which one is fracture.A.If just one, please provide that lot#:.2.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 3.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.4.Was the patient hospitalized or was there prolonged hospitalization? 5.Did the patient require any additional procedures due to this occurrence? 6.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify: additional procedures and provide details.7.Has the complainant reported any adverse effects on the patient due to this occurrence? 8.Has the complainant reported that the product caused or contributed to the adverse effects? 9.Please specify: adverse effects and provide details.10.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.A.If other, please specify:.11.Was a stent previously placed during previous procedures? 12.Was the device used percutaneously? 13.Where on the patient was the percutaneous access site? 14.Was the access site jugular or femoral? n/a, jugular, femoral other.A.If other, please specify:.15.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? a.If other, please specify:.16.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.17.Was pre-dilation performed ahead of placement of the stent? 18.What was the target location for the stent? 19.Details of access sheath used (name, fr size, length)? 20.Was the device flushed through both flushing ports before the procedure, as per ifu? 21.Details of the wire guide used (name, diameter, hyrdophyllic)? 22.Was resistance encountered when advancing the wire guide to the target location? 23.Was resistance encountered when advancing the delivery system to the target location? 24.If resistance was met, how did the physician address this? 25.Did the tip of the delivery system cross the target location? 26.Did the user pull the handle towards the hub during deployment, per ifu? 27.Did the user push the hub during deployment? 28.Did the user remove slack in the delivery system before deployment, per ifu? 29.Was the stent deployed smoothly / without resistance? 30.Was the stent fully deployed in the patient? 31.Was the stent fully deployed before removing the delivery system from the patient? 32.Was post dilation performed after the placement of the stent? 33.Was the delivery system damaged/kinked/twisted during deployment? 34.What intervention (if any) was required? 35.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day.36.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify: if yes.The following information has been received via email on 22 mar 2023.(b)(6) 22 mar 2023 1.Did both lot#: c1766826 & c1799437 fracture, or just one of them? we don¿t know which stent was placed proximally to identify which one is fracture.A.If just one, please provide that lot#:.2.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 17 year old male, may thuner, prior dvts.3.Did any unintended section of the device remain inside the patient¿s body? no.A.If yes, please describe.4.Was the patient hospitalized or was there prolonged hospitalization? no.5.Did the patient require any additional procedures due to this occurrence? patient had another dvt.6.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify: additional procedures and provide details.7.Has the complainant reported any adverse effects on the patient due to this occurrence? 8.Has the complainant reported that the product caused or contributed to the adverse effects? 9.Please specify, adverse effects and provide details.10.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other, nothing out of the ordinary.A.If other, please specify:.11.Was a stent previously placed during previous procedures? not before the zilver venas were placed.12.Was the device used percutaneously? yes.13.Where on the patient was the percutaneous access site? pop, patient was prone.14.Was the access site jugular or femoral? n/a, jugular, femoral, other.A.If other, please specify: pop, patient was prone.15.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? a.If other, please specify: may thurner.16.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.17.Was pre-dilation performed ahead of placement of the stent? yes.18.What was the target location for the stent? ostium of common iliac.19.Details of access sheath used (name, fr size, length)? 12 fr sheath for penumbra device.20.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.21.Details of the wire guide used (name, diameter, hyrdophyllic)? 22.Was resistance encountered when advancing the wire guide to the target location? minimal.23.Was resistance encountered when advancing the delivery system to the target location? 24.If resistance was met, how did the physician address this? 25.Did the tip of the delivery system cross the target location? yes.26.Did the user pull the handle towards the hub during deployment, per ifu? yes.27.Did the user push the hub during deployment? no.28.Did the user remove slack in the delivery system before deployment, per ifu? yes.29.Was the stent deployed smoothly / without resistance? yes.30.Was the stent fully deployed in the patient? yes.31.Was the stent fully deployed before removing the delivery system from the patient? yes.32.Was post dilation performed after the placement of the stent? yes.33.Was the delivery system damaged/kinked/twisted during deployment? no.34.What intervention (if any) was required? twice after the stent, the patient had dvts.35.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day it, was months later.36.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify: if yes.The following information has been requested via email on 24 mar 2023.(b)(6) 24 mar 2023.Can you confirm what they mean by pop placement.1.Where on the patient was the percutaneous access site? pop, patient was prone.2.Was the access site jugular or femoral? n/a, jugular, femoral, other.A.If other, please specify: pop, patient was prone.The following information has been received via email on 28.Mar.2023.(b)(6) 29 mar 2023.The popliteal vein.The following information has been requested via email on 29 mar 2023.(b)(6) 29 mar 2023.1.Please provide clarification on whether the 12fr access sheath was used during the original procedure or during the follow up procedure a year later? 2.Details of access sheath used (name, fr size, length)? 12 fr sheath for penumbra device.The following information has been received via email on 31 mar 2023.(b)(6) 31 mar 2023.12 french sheath was used during both procedures for the penumbra thrombectomy.It was a cook short sheath.

Manufacturer Narrative

Pma/510(k) # p200023.Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required this complaint is related to (b)(4) (emdr 3001845648-2023-00186), (emdr ref.-3001845648-2023-00283), (b)(4) (emdr ref.-3001845648-2023-00284) and (b)(4) (emdr ref.-3001845648-2023-00261).The zvt7-35-120-16-100 device of lot number c1766826 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: the review of relevant manufacturing records confirms the failure mode has previously occurred for this work order.(b)(4) was raised to capture the user error of a 8fr access sheath used where as 7fr is stated in the ifu.This user error is deemed unforeseen misuse and is not related to a device defect therefore would not be considered related to any possible manufacturing issue related to lot number c1766826.Instructions for use/label.It should be noted that the instructions for use (ifu0091) states the following: ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.There is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause of the user not reading or following the instructions for use has been determined.From the additional questions it is known that an 12fr access sheath was used with the device.As previously noted, the ifu states ¿gain access at the appropriate site utilizing a 2.3mm (7.0 french) introducer sheath¿.Confirmation of complaint: the complaint is confirmed based on customer and/or rep testimony.Summary: according to the additional information received, it is known that an 12fr access sheath was used with the device.The ifu instructs to use a 7fr access sheath.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu.From the information available, it is known that an 12fr access sheath was used with the device and not the intended 7fr size as required as per the ifu.The complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This supplemental report is being submitted due to the completion of the investigation on the 26-jun-2023.

Event Description

Supplemental follow-up correction mdr report is being submitted due to the update of description of event and lot number.Pr (b)(4) (emdr ref.-3001845648-2023-00282) will capture the user error of the original lot number c1766826.Description of event: per email: i met with a physician who shared with me some images of a previous zilver vena placed that has now fractured.(pr (b)(4)) the patient returned due to re-thrombosing and the doctor placed an additional stent in the proximal piece that was fractured.Two stents were placed that day and are listed below.Account: (b)(6) g57454: (b)(4) g57454: (b)(4) original case date was (b)(6) 2022 12fr access sheath was used in the initial procedure related to pr (b)(4).This file will capture the use of a 12fr access sheath with the initial device lot number c1766826 patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? no 2.Was the patient hospitalized or was there prolonged hospitalization? no 3.Did the patient require any additional procedures due to this occurrence? patient had another dvt 4.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? 6.Has the complainant reported that the product caused or contributed to the adverse effects? a.Please specify adverse effects and provide details." patient/event info - notes: the following information has been requested via email on27feb2023.Sg 27feb2023 please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other if other, please specify: was a stent previously placed during previous procedures? was the device used percutaneously? where on the patient was the percutaneous access site? was the access site jugular or femoral? n/a, jugular, femoral other if other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify: was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral was pre-dilation performed ahead of placement of the stent? what was the target location for the stent? details of access sheath used (name, fr size, length)? was the device flushed through both flushing ports before the procedure, as per ifu? details of the wire guide used (name, diameter, hyrdophyllic)? was resistance encountered when advancing the wire guide to the target location? was resistance encountered when advancing the delivery system to the target location? if resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? did the user pull the handle towards the hub during deployment, per ifu? did the user push the hub during deployment? did the user remove slack in the delivery system before deployment, per ifu? was the stent deployed smoothly / without resistance? was the stent fully deployed in the patient? was the stent fully deployed before removing the delivery system from the patient? was post dilation performed after the placement of the stent? was the delivery system damaged/kinked/twisted during deployment? what intervention (if any) was required? was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? please specify if yes.Per rep: i am trying to schedule a meeting with the doc to answer the unanswered questions, but children¿s is not an easy hospital to get access to.Sg 02mar2023 7.Will the product be returned? no, still in the patient 8.Usage of product: a.Initial use of device; correct b.Reuse of device c.Unknown 9.Was product reprocessed for reuse prior to occurrence? 10.Did the product regarding this complaint come in contact with the patient? 11.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 12.What type of procedure was being performed? thrombectomy and venogram 13.Did the event result in a death? no 14.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.15.Was the patient hospitalized or was there prolonged hospitalization? 16.Did the patient require any additional procedures due to this occurrence? 17.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.18.Has the complainant reported any adverse effects on the patient due to this occurrence? 19.Has the complainant reported that the product caused or contributed to the adverse effects? 20.Please specify adverse effects and provide details.21.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other a.If other, please specify: 22.Was a stent previously placed during previous procedures? 23.Was the device used percutaneously? 24.Where on the patient was the percutaneous access site? 25.Was the access site jugular or femoral? n/a, jugular, femoral other a.If other, please specify: 26.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? a.If other, please specify: 27.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral 28.Was pre-dilation performed ahead of placement of the stent? 29.What was the target location for the stent? 30.Details of access sheath used (name, fr size, length)? 31.Was the device flushed through both flushing ports before the procedure, as per ifu? 32.Details of the wire guide used (name, diameter, hyrdophyllic)? 33.Was resistance encountered when advancing the wire guide to the target location? 34.Was resistance encountered when advancing the delivery system to the target location? 35.If resistance was met, how did the physician address this? 36.Did the tip of the delivery system cross the target location? 37.Did the user pull the handle towards the hub during deployment, per ifu? 38.Did the user push the hub during deployment? 39.Did the user remove slack in the delivery system before deployment, per ifu? 40.Was the stent deployed smoothly / without resistance? 41.Was the stent fully deployed in the patient? 42.Was the stent fully deployed before removing the delivery system from the patient? 43.Was post dilation performed after the placement of the stent? 44.Was the delivery system damaged/kinked/twisted during deployment? 45.What intervention (if any) was required? 46.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 47.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify if yes.The following information has been requested via email by pmqe on 20mar2023.Sg 20mar2023 1.Did both lot # c1766826 & c1799437 fracture, or just one of them? we don¿t know which stent was placed proximally to identify which one is fracture a.If just one, please provide that lot #.2.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 3.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.4.Was the patient hospitalized or was there prolonged hospitalization? 5.Did the patient require any additional procedures due to this occurrence? 6.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.7.Has the complainant reported any adverse effects on the patient due to this occurrence? 8.Has the complainant reported that the product caused or contributed to the adverse effects? 9.Please specify adverse effects and provide details.10.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other a.If other, please specify: 11.Was a stent previously placed during previous procedures? 12.Was the device used percutaneously? 13.Where on the patient was the percutaneous access site? 14.Was the access site jugular or femoral? n/a, jugular, femoral other a.If other, please specify: 15.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? a.If other, please specify: 16.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral 17.Was pre-dilation performed ahead of placement of the stent? 18.What was the target location for the stent? 19.Details of access sheath used (name, fr size, length)? 20.Was the device flushed through both flushing ports before the procedure, as per ifu? 21.Details of the wire guide used (name, diameter, hyrdophyllic)? 22.Was resistance encountered when advancing the wire guide to the target location? 23.Was resistance encountered when advancing the delivery system to the target location? 24.If resistance was met, how did the physician address this? 25.Did the tip of the delivery system cross the target location? 26.Did the user pull the handle towards the hub during deployment, per ifu? 27.Did the user push the hub during deployment? 28.Did the user remove slack in the delivery system before deployment, per ifu? 29.Was the stent deployed smoothly / without resistance? 30.Was the stent fully deployed in the patient? 31.Was the stent fully deployed before removing the delivery system from the patient? 32.Was post dilation performed after the placement of the stent? 33.Was the delivery system damaged/kinked/twisted during deployment? 34.What intervention (if any) was required? 35.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 36.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify if yes.The following information has been received via email on 22mar2023.Sg 22mar2023 1.Did both lot # c1766826 & c1799437 fracture, or just one of them? we don¿t know which stent was placed proximally to identify which one is fracture a.If just one, please provide that lot #.2.Can you provide any patient information (age, weight, gender, pre-existing conditions)? 17 year old male, may thuner, prior dvts 3.Did any unintended section of the device remain inside the patient¿s body? no a.If yes, please describe.4.Was the patient hospitalized or was there prolonged hospitalization? no 5.Did the patient require any additional procedures due to this occurrence? patient had another dvt 6.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.7.Has the complainant reported any adverse effects on the patient due to this occurrence? 8.Has the complainant reported that the product caused or contributed to the adverse effects? 9.Please specify adverse effects and provide details.10.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other nothing out of the ordinary a.If other, please specify: 11.Was a stent previously placed during previous procedures? not before the zilver venas were placed 12.Was the device used percutaneously? yes 13.Where on the patient was the percutaneous access site? pop, patient was prone 14.Was the access site jugular or femoral? n/a, jugular, femoral other a.If other, please specify: pop, patient was prone 15.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? a.If other, please specify: may thurner 16.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral 17.Was pre-dilation performed ahead of placement of the stent? yes 18.What was the target location for the stent? ostium of common iliac 19.Details of access sheath used (name, fr size, length)? 12 fr sheath for penumbra device 20.Was the device flushed through both flushing ports before the procedure, as per ifu? yes 21.Details of the wire guide used (name, diameter, hyrdophyllic)? 22.Was resistance encountered when advancing the wire guide to the target location? minimal 23.Was resistance encountered when advancing the delivery system to the target location? 24.If resistance was met, how did the physician address this? 25.Did the tip of the delivery system cross the target location? yes 26.Did the user pull the handle towards the hub during deployment, per ifu? yes 27.Did the user push the hub during deployment? no 28.Did the user remove slack in the delivery system before deployment, per ifu? yes 29.Was the stent deployed smoothly / without resistance? yes 30.Was the stent fully deployed in the patient? yes 31.Was the stent fully deployed before removing the delivery system from the patient? yes 32.Was post dilation performed after the placement of the stent? yes 33.Was the delivery system damaged/kinked/twisted during deployment? no 34.What intervention (if any) was required? twice after the stent, the patient had dvts 35.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day it was months later 36.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? a.Please specify if yes.The following information has been requested via email on 24mar2023.Sg 24mar2023 can you confirm what they mean by pop placement, 1.Where on the patient was the percutaneous access site? pop, patient was prone 2.Was the access site jugular or femoral? n/a, jugular, femoral other a.If other, please specify: pop, patient was prone the following information has been received via email on 28mar2023.Sg 29mar2023 the popliteal vein the following information has been requested via email on 29mar2023.Sg 29mar2023 1.Please provide clarification on whether the 12fr access sheath was used during the original procedure or during the follow up procedure a year later 2.Details of access sheath used (name, fr size, length)? 12 fr sheath for penumbra device the following information has been received via email on 31mar2023.Sg 31mar2023 12 french sheath was used during both procedures for the penumbra thrombectomy.It was a cook short sheath.

Manufacturer Narrative

Pma/510(k) # p200023 investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16830735
• MDR Text Key: 314194651
• Report Number: 3001845648-2023-00282
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574547
• UDI-Public: (01)10827002574547(17)231009(10)C1766826
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2023
• Device Model Number: G57454
• Device Catalogue Number: ZVT7-35-120-16-100
• Device Lot Number: C1766826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male