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

Model Number G57444

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440); Respiratory Insufficiency (4462)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Common device name: nio stent, iliac.Product code: qan.Pma/510(k) #: p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Stent is already deployed in the patient.The procedure went great on tuesday; doctor texted dm today that the patient called in; patient was supposed to be coming in for a duplex ultrasound and, while putting on his shoes, patient experienced chest pain and shortness of breath.At that point the doctor told the patient to come into the e.R.In e.R., they observed that the stent had migrated to left pulmonary artery.Doctor believes that the stent probably thrombosed prior to embolizing.Patient was fully anticoagulated (dm believes this means during the procedure).Doctor said that the patient had no underlying clotting disorder and was seen by hemotology.No breakage of the device has been observed.Patient will be having the stent removed (possibly already done today)." additional information provided by dm on 14may2021: " can the stent be confirmed as available for return to cook? looking into that.From dr.(b)(6) : patient wife said he has an allergy to bee venom, ct was done afterwards  iliac vein was clean.Possible unknown allergy to stent metal? thrombosis came first  maybe an allergic reaction with an odd inflammatory response under stent  was not able to endothelialize to vessel walls.Image of stent after extraction." patient outcome: did any unintended section of the device remain inside the patients body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? yes.If yes, please describe.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Patient/event info - notes: are images of the device or procedure available? n/a,yes,no yes working on this did the patient have pre-existing conditions? n/a, yes, no.If yes, please specify: allergy to bee venom.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: patient had venous compression in left iliac vein was a stent previously placed during previous procedures? n/a, yes, no yes was the device used percutaneously? n/a,yes,no yes where on the patient was the percutaneous access site? right jugular vein was the access site jugular or femoral? n/a, jugular, femoral other jugular if other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? may thurner.If other, please specify.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral n/a right jugular vein.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no no what was the target location for the stent? left common iliac vein extending to external iliac vein.Details of access sheath used (name, fr size, length)? 9fr 13cm terumo sheath was the device flushed through both flushing ports before the procedure, as per ifu? n/a,yes,no yes.Details of the wire guide used (name, diameter, hyrdophyllic)? 035 180cm rosen wire cook medical.Was resistance encountered when advancing the wire guide to the target location? n/a, yes, no no.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no no.If resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? n/a,yes,no yes.Did the user pull the handle towards the hub during deployment, per ifu? n/a,yes,no yes did the user push the hub during deployment? n/a, yes, no no.Did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no yes.Was the stent deployed smoothly / without resistance? n/a, yes, no yes.Was the stent fully deployed in the patient? n/a, yes, no yes.Was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no yes.Was post dilation performed after the placement of the stent? n/a, yes, no yes.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no no.What intervention (if any) was required? extraction of stent in pulmonary artery.Stent thrombosed and migrated.Pfo closure needed.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 another day.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no no.Please specify if yes.

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - qan.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 image review.Image review received 9-aug-2021: is the complaint confirmed? (see description of event on complaint report) no or yes.Findings: 1.Implantation angiography and ivus are provided along with the complaint report.2.The complaint concerns zvt7-35-80-14-60 pulmonary artery embolization two days post implantation.The stent was reportedly retrieved.The complaint report implies that the retrieved stent was filled with thrombus.3.The stent was implanted from the right ij.The pre-stent ivus was performed in pull back fashion from the left eiv to the ivc.4.The implantation site was the distal left civ from the eiv/iiv confluence to just inferior to the right cia crossing.(figure 1) 5.On venography, the civ vein segment was 14mm x 16mm in two projections.(figure 1 & figure 2) 6.On pre-stent ivus, the civ segment was a flattened ellipse with a 50% area stenosis.No intravenous synechiae or webs were demonstrated.The adjacent vein diameter was 15mm.(figure 3) the segment was adjacent to the left cia and inferior to the right cia crossing.(figure 4) 7.On post-stent implantation venography, although the stent was completely expanded, it was not circumferentially apposed to the vein wall.(figure 5) on ivus, a gap was present between the vein wall and the mid through superior stent.(figure 6) an area of stagnant contrast between the stent and the vein wall was evident on venography (figure 7).The gap containing the stagnant contrast was partially obscured on ivus by trapped contrast, tiny gas bubbles, or developing thrombus.Post-implantation, thrombus was present on the ivus catheter (figure 8) and the stent (figure 9).Impression: 1.The complaint of stent embolization from the left civ to the pulmonary arteries cannot be confirmed because imaging of the event was not provided.2.The stent was undersized relative to the entire segment on venography and to the adjacent reference vein diameter on ivus.Gaps between the vein wall and stent reduced the stent¿s anchoring capacity and created areas of flow stagnation.Flow stagnation is pro-thrombotic.3.Thrombus on the ivus catheter and stent were present near the termination of the procedure.4.The stent was implanted below the right cia crossing.

Manufacturer Narrative

Pma/510(k) #: (b)(4).Section d: common name - qan.Device evaluation: the zvt7-35-80-14-60 device of lot number c1764721 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review prior to distribution zvt7-35-80-14-60 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 zvt7-35-80-14-60 of lot number c1764721 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has or 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 c1764721.It should be noted that the instructions for use ifu0091-7.There is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: impression: 1.The complaint of stent embolization from the left civ to the pulmonary arteries cannot be confirmed because imaging of the event was not provided.2.The stent was undersized relative to the entire segment on venography and to the adjacent reference vein diameter on ivus.Gaps between the vein wall and stent reduced the stent¿s anchoring capacity and created areas of flow stagnation.Flow stagnation is pro-thrombotic.3.Thrombus on the ivus catheter and stent were present near the termination of the procedure.4.The stent was implanted below the right cia crossing.Root cause review: a definitive root cause of user error was identified from the available information.The physician selected an undersized stent for this patient and this would have contributed to stent migration.Summary: complaint is confirmed as the failure was verified in the images provided.Stent migration was observed in the image review.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient reported chest pain and shortness of breath, which was likely due the stent migration.The patient required additional procedure due to this occurrence ¿ the stent was extracted in the pulmonary artery some days after the placement of the stent.Complaints of this nature will continue to be monitored for potential emerging trends.It should be noted that the physician provided more information regarding patient history.The physician noted that the patient is allergic to bee venom.However there is no evidence to suggest the patient was allergic to any metal component of the stent.

Event Description

Confirmation received from medical advisor on (b)(6) 2021 that event would be considered life threatening.Supplemental report is being submitted due to the completion of the investigation.

Event Description

Supplemental correction report is being submitted due to the update of imdrf cause investigation: investigation findings (annex c), from c13 (operational problem identified) to c23 (usage problem identified) on (b)(6) 2023.

Manufacturer Narrative

Pma/510(k) #p200023 device evaluation the zvt7-35-80-14-60 device of lot number c1764721 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation ¿ n/a document review prior to distribution zvt7-35-80-14-60 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 zvt7-35-80-14-60 of lot number c1764721 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has or 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 c1764721.It should be noted that there is evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression 1.The complaint of stent embolization from the left civ to the pulmonary arteries cannot be confirmed because imaging of the event was not provided.2.The stent was undersized relative to the entire segment on venography and to the adjacent reference vein diameter on ivus.Gaps between the vein wall and stent reduced the stent¿s anchoring capacity and created areas of flow stagnation.Flow stagnation is pro-thrombotic.3.Thrombus on the ivus catheter and stent were present near the termination of the procedure.4.The stent was implanted below the right cia crossing.Root cause review a definitive root cause of user error was identified from the available information.The physician selected an undersized stent for this patient and this would have contributed to stent migration.Summary complaint is confirmed as the failure was verified in the images provided.Stent migration was observed in the image review.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient reported chest pain and shortness of breath, which was likely due the stent migration.The patient required additional procedure due to this occurrence ¿ the stent was extracted in the pulmonary artery some days after the placement of the stent.Complaints of this nature will continue to be monitored for potential emerging trends.It should be noted that the physician provided more information regarding patient history.The physician noted that the patient is allergic to bee venom.However there is no evidence to suggest the patient was allergic to any metal component of the stent.

• 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 ; 061334440
• MDR Report Key: 11981276
• MDR Text Key: 255629620
• Report Number: 3001845648-2021-00461
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574448
• UDI-Public: (01)10827002574448(17)231005(10)C1764721
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: G57444
• Device Catalogue Number: ZVT7-35-80-14-60
• Device Lot Number: C1764721
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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; Life Threatening
• Patient Age: 48 YR
• Patient Sex: Male