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

Catalog Number UNKNOWN

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Leg claudication and us showed in-stent restenosis at the edge of the zilver ptx after 2 years.Mr (b)(6) proceeded to plasty the lesion and use a dcb.

Manufacturer Narrative

Pma/510(k) # = p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).Device evaluation: the unknown 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 rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all zisv6 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.It may be noted that the instructions for use lists restenosis of the stented artery as a known potential adverse event.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: the single image is consistent with a post angioplasty moderate to severe stenosis from neointimal hyperplasia at the distal end of a right eia into cfa artery zilver ptx stent.Outflow was limited by the moderate stenosis of the distal cfa and the sfa occlusion.The mid cfa location placed the stent end at where the cfa bends with hip flexion.Root cause review: a definitive root cause of a moderate to severe stenosis from neointimal hyperplasia into the zilver ptx stent was identified from the imaging review.From the information provided it is possible that the patient¿s age at the time of the event and disease progression were contributing factors.Summary: complaint is confirmed as the failure was verified in the image(s).A moderate to severe stenosis from neointimal hyperplasia into the zilver ptx stent was identified from the imaging review.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

Leg claudication and us showed in-stent restenosis at the edge of the zilver ptx after 2 years.Mr (b)(6) proceeded to plasty the lesion and use a dcb.

• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8160344
• MDR Text Key: 130219635
• Report Number: 3001845648-2018-00581
• 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
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR