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

Model Number G57449

Device Problems Improper or Incorrect Procedure or Method (2017); Structural Problem (2506); Deformation Due to Compressive Stress (2889)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Per rep - (b)(6) 2021 - after the physician deployed the stent in the left iliac, the 1st 75 % of the proximal stent deployed well and fully open.Then the distal 25 % of the stent did not fully open and remained compressed.After seeing this, the physician tried to balloon that part of the stent multiple times but each time, after ballooning, the stent would just compress again.After this, the physician had to line the inside of the stent with a competitive stent.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Patient/event info: notes: examples of rpn prefixes (but not limited to): zib5, zib6, ziv5, zisv6, zvt7, ziv6.General questions for complaint occurring during use, request the following: where was the access site? left groin.What was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.Somewhat tortuous, possibly scarred.What was the target location for the stent? left iliac.Was the target location severely calcified or tortuous? tortuous was the device flushed prior to use? yes.Were there any difficulties deploying the stent? no.Was the stent fully deployed before removing the delivery system from the patient? yes.What other devices were used in the procedure? phillips ivus, a bard atlas balloon, wires, 8fr sheath.Please provide manufacturer, model, brand, and size if possible.Phillips ivus, a bard atlas balloon, wires, 8fr sheath.Were any additional procedures necessary as a result of this event? no.Can any photos, images, or reports of the procedure or device be provided? no.Please review following ¿failure¿ modes with contact to determine if additional questions apply: if the event involves thombosis, restenosis, and/or occlusion, request the following: n/a.Did the patient have any risk factors for thrombosis, restenosis, or occlusion? what other medications and/or treatments was the patient receiving? if occlusion occurred, can it be confirmed if the occlusion is related to thrombosis or restenosis? if the event involved claudication / pain, request the following: is the reported event a symptom of restenosis or thrombosis? no.If no restenosis or thrombosis occurred how it was determined that the zilver stents caused / contributed to the event? the stent would not fully open.If the event involves stent shortening, request the following: n/a.Was there any evidence of post deployment stent compression or deformation? was the delivery system able to be advanced to the target site easily / with no resistance? was the handle pulled toward the hub while the delivery system remained stationary during deployment? if the event involves sheath separation, request the following: n/a.Was there high resistance encountered during any part of the procedure, wire guide advancement, stent deployment, etc.? was pre-dilatation conducted prior to stent deployment? was the handle puled toward the hub while the delivery system remained stationary during deployment? if the event involving deployment difficulties, request the following: n/a.Was the stent eventually deployed? was pre-dilatation conducted before stent deployment? was the handle pulled toward the hub while the delivery system remained stationary during deployment? if the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: n/a.Was the wire guide hydrophilic or non-hydrophilic? how long was the procedure from advancing delivery system to the moment when the user attempted to remove the device? was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? if used, was the wire guide wiped between uses?.

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - (b)(6).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow-up report is being submitted due to the receipt of additional information on 07-apr-2021 as follows: the rep has provided the answers to the following questions.1.Was the device used percutaneously? -yes.2.Where on the patient was the percutaneous access site? -groin.3.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? -chronic obstruction.If other, please specify.4.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral -ipsilateral.5.Was pre-dilation performed ahead of placement of the stent? -yes.6.Did the user remove slack in the delivery system before deployment, per ifu? -yes.7.Was the delivery system damaged/kinked/twisted during deployment? -no.8.Please specify if yes.-n/a.Initial report details: per rep - (b)(6) 2021 - after the physician deployed the stent in the left iliac, the 1st 75 % of the proximal stent deployed well and fully open.Then the distal 25 % of the stent did not fully open and remained compressed.After seeing this, the physician tried to balloon that part of the stent multiple times but each time, after ballooning, the stent would just compress again.After this, the physician had to line the inside of the stent with a competitive stent.Patient outcome: did any unintended section of the device remain inside the patient¿s body? -no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? -no.Did the patient require any additional procedures due to this occurrence? -no.If yes, please describe.Did the product cause or contribute to the need for additional procedures? -no.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? -no.Has the complainant reported that the product caused or contributed to the adverse effects? -no.Please specify adverse effects and provide details.Patient/event info - notes: 1.0 examples of rpn prefixes (but not limited to): zib5 zib6 ziv5.Zisv6 zvt7 ziv6.1.1 general questions for complaint occurring during use, request the following: 1.2 where was the access site? -left groin.1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.-somewhat tortuous, possibly scarred.1.4 what was the target location for the stent? -left iliac.¿ was the target location severely calcified or tortuous? -tortuous.1.5 was the device flushed prior to use? -yes.1.6 were there any difficulties deploying the stent? -no.1.7 was the stent fully deployed before removing the delivery system from the patient? -yes.1.8 what other devices were used in the procedure? -phillips ivus, a bard atlas balloon, wires, 8fr sheath.¿ please provide manufacturer, model, brand, and size if possible.-phillips ivus, a bard atlas balloon, wires, 8fr sheath.1.9 were any additional procedures necessary as a result of this event? -no.1.10 can any photos, images, or reports of the procedure or device be provided? -no.2.0 please review following ¿failure¿ modes with contact to determine if additional questions apply.2.1 if the event involves thombosis, restenosis, and/or occlusion, request the following: -n/a.2.1.1 did the patient have any risk factors for thrombosis, restenosis, or occlusion? 2.1.2 what other medications and/or treatments was the patient receiving? 2.1.3 if occlusion occurred, can it be confirmed if the occlusion is related to thrombosis or restenosis? 2.2 if the event involved claudication / pain, request the following: 2.2.1 is the reported event a symptom of restenosis or thrombosis? -no.2.2.2 if no restenosis or thrombosis occurred how it was determined that the zilver stents caused / contributed to the event? -the stent would not fully open.2.3 if the event involves stent shortening, request the following: -n/a.2.3.1 was there any evidence of post deployment stent compression or deformation? 2.3.2 was the delivery system able to be advanced to the target site easily / with no resistance? 2.3.3 was the handle pulled toward the hub while the delivery system remained stationary during deployment? 2.4 if the event involves sheath separation, request the following: -n/a.2.4.1 was there high resistance encountered during any part of the procedure, wire guide advancement, stent deployment, etc.? 2.4.2 was pre-dilatation conducted prior to stent deployment? 2.4.3 was the handle puled toward the hub while the delivery system remained stationary during deployment? 2.5 if the event involving deployment difficulties, request the following: -n/a.2.5.1 was the stent eventually deployed? 2.5.2 was pre-dilatation conducted before stent deployment? 2.5.3 was the handle pulled toward the hub while the delivery system remained stationary during deployment? 2.6 if the event that involve device stuck on wire guide, difficult to advance / remove delivery system and/or wire guide, request the following: -n/a.2.6.1 was the wire guide hydrophilic or non-hydrophilic? 2.6.2 how long was the procedure 0from advancing delivery system to the moment when the user attempted to remove the device? 2.6.3 was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? 2.6.3.1 if used, was the wire guide wiped between uses?.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.Device evaluation: the zvt7-35-80-16-140 device of lot number c1769826 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.Document review : prior to distribution zvt7-35-80-16-140 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl: a review of the manufacturing records for zvt7-35-80-16-140 of lot number c1769826 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1769826.It should be noted that the instructions for use (ifu0091-7) states the following: venous access for venous access, the use of an access set that accepts a 2.3 mm (7.0 french) introducer catheter is recommended.There is evidence to suggest the user did not follow the instructions for use as according to the customer testimony an 8fr sheath was used in the procedure.Root cause review: a definitive root cause of user error was identified from the available information.The instructions for use recommend a 7.0 french catheter is used and the customer testified that and 8fr sheath was used.The use of the other than recommended sheath size may have contributed to 25% of the stent remaining compressed following deployment.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p200023.Device evaluation the zvt7-35-80-16-140 device of c1769826 lot number 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.This file is related to (b)(4) (emdr ref.-3001845648-2023-00210) which was opened to capture the use of an incorrect size access sheath.Lab evaluation ¿ n/a.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records revealed a non-conformance for embedded fm (pac-002) was noted on this work order however this could not have contributed to this complaint issue.The review of the relevant manufacturing records confirms the failure mode has not previously occurred for this work order.It should be noted that the instructions for use lists "abrupt stent closure" as a potential adverse event.There is no evidence to suggest that the customer did not follow the instructions for use or label.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined however a possible root cause could be attributed to difficult patient anatomy.From the information provided it is known that the patient¿s anatomy was somewhat tortuous and possibly scarred with the target location noted to be tortuous.It is possible that compressive forces from the difficult anatomy may have caused or contributed to 25% of the stent remaining compressed on deployment.Also, as previously noted the instructions for use lists "abrupt stent closure" as a potential adverse event.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required the implantation of a second stent, within the same operating procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 11633771
• MDR Text Key: 261314243
• Report Number: 3001845648-2021-00277
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)231021(10)C1769826
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1769826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 03/11/2021; 03/11/2021; 03/11/2021
• Supplement Dates FDA Received: 05/07/2021; 10/22/2021; 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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 Outcome(s): Required Intervention
• Patient Sex: Male