MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-5.0-120-PTX

Device Problem Fracture (1260)

Patient Problem Aneurysm (1708)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # : this specific device rpn is not marketed in the us.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As per problem statement: aneurysm on stent fracture.Rep (b)(6) reported via phone.02.October 2018 07:56 am.Lot number and product to be confirmed.Product wont return.As per complaint form: on (b)(6) 2015, dr.(b)(6) placed a zptx (zisv6-35-125-5.0-120-ptx) on a patient with occlusion p2/pop in the right leg.Good outcome, no problems occurred during the intervention.No more information about other used products.The intervention is too long ago.In (b)(6) 2017, dr.(b)(6) did a reintervention, as the patient came back with discomfort.The previous stent (zisv6-35-125-5.0-120-ptx) looked very good, was completely open and still like a highway.But proximal a new stenosis, which was treated with another zptx.Good outcome.On (b)(6) patient came back again with new discomfort in the right leg.Dr.(b)(6) found a huge aneurysm (popliteal) and a complete straight fracture of the zilver ptx in the distal stent-area.The stent separated about 1.5 cm.This must now be "repaired" with a bypass.As per email from rep 04-oct-2018: forget about the second much shorter zptx which was implanted (sfa) last year.No relevance to the complaint.The zisv6-35-125-5.0-120-ptx is fractured (located popliteal p2) at the distal end of the stent.You will see it when you receive the cd.

Event Description

As per problem statement: aneurysm on stent fracture.Rep (b)(6) reported via phone.02.October 2018 07:56 am.Lot number and product to be confirmed.Product wont return.As per complaint form: on (b)(6) 2015, dr.(b)(6) placed a zptx (zisv6-35-125-5.0-120-ptx) on a patient with occlusion p2/pop in the right leg.Good outcome, no problems occurred during the intervention (see cd).No more information about other used products.The intervention is too long ago.In (b)(6) 2017, dr.(b)(6) did a reintervention, as the patient came back with discomfort.The previous stent (zisv6-35-125-5.0-120-ptx) looked very good, was completely open and still like a highway.But proximal a new stenosis, which was treated with another zptx.Good outcome.On 1 of october patient came back again with new discomfort in the right leg.Dr.Sixt found a huge aneurysm (popliteal) and a complete straight fracture of the zilver ptx in the distal stent-area.The stent separated about 1.5 cm.This must now be "repaired" with a bypass.As per email from rep 04-oct-2018: forget about the second much shorter zptx which was implanted (sfa) last year.No relevance to the complaint.The zisv6-35-125-5.0-120-ptx is fractured (located popliteal p2) at the distal end of the stent.You will see it when you receive the cd.

Manufacturer Narrative

Pma/510(k) # : this specific device rpn is not marketed in the us.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As per problem statement: aneurysm on stent fracture.Rep (b)(6) reported via phone.(b)(6)2018 07:56 am.Lot number and product to be confirmed.Product wont return.As per complaint form: on (b)(6)2015, dr.Sixt placed a zptx (zisv6-35-125-5.0-120-ptx) on a patient with occlusion p2/pop in the right leg.Good outcome, no problems occurred during the intervention (see cd).No more information about other used products.The intervention is too long ago.In september 2017, dr.Sixt did a reintervention, as the patient came back with discomfort.The previous stent (zisv6-35-125-5.0-120-ptx) looked very good, was completely open and still like a highway.But proximal a new stenosis, which was treated with another zptx.Good outcome.On 1 of october patient came back again with new discomfort in the right leg.Dr.Sixt found a huge aneurysm (popliteal) and a complete straight fracture of the zilver ptx in the distal stent-area.The stent separated about 1.5 cm.This must now be "repaired" with a bypass.As per email from rep (b)(6)2018: forget about the second much shorter zptx which was implanted (sfa) last year.No relevance to the complaint.The zisv6-35-125-5.0-120-ptx is fractured (located popliteal p2) at the distal end of the stent.You will see it when you receive the cd.

Manufacturer Narrative

Pma/510(k) # : this specific device rpn is not marketed in the us.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: (b)(4).Information pertaining to mfr site as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Device evaluation the zisv6-35-125-5.0-120-ptx device of unknown 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.Document review as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subject to visual inspection and functional checks to ensure device integrity.Ifu review it should be noted that stent strut fracture is listed as a known potential adverse event in the instructions for use.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 post-implantation stent fracture and pa aneurysm formation is confirmed.The fracture was likely the result of the increased stress placed on the stent by the aneurysm during knee flexion.Aneurysm formation as result of the stent fracture or palictaxel is unlikely given the classic pa (popliteal artery) aneurysm appearance.2.The unusual development of a peri-stent sfa aneurysm indicates arteries prone to aneurysm formation.3.Small angiographically invisible pa aneurysms are not uncommon on cta and may likely have unknowingly existed at implantation.Although a literature search yielded no publications regarding this, in our own practice we have completely abandoned diagnostic angiography for cta for this reason.Root cause review as per the imaging review, the fracture was likely the result of the increased stress placed on the stent by the aneurysm during knee flexion and the unusual development of a peri-stent superficial femoral artery (sfa) aneurysm indicates arteries prone to aneurysm formation.It may be noted that as per the imaging review the pa aneurysm may have been present at the time of implantation of the stent and was not visible on the computed tomography angiography (cta) images.Summary complaint is confirmed as the failure was verified in the image(s).Stent fracture post implantation and a popliteal artery (pa) aneurysm were observed in the imaging.According to the initial reporter, the patient required open bypass surgery (femoral-popliteal bypass).Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8018599
• MDR Text Key: 125443457
• Report Number: 3001845648-2018-00505
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-5.0-120-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 10/02/2018; 10/02/2018
• Supplement Dates FDA Received: 11/27/2018; 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention