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

Catalog Number ZISV6-35-80-6.0-100-PTX

Device Problems Fracture (1260); Compatibility Problem (2960)

Patient Problem No Code Available (3191)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Pma #p100022/s014.(b)(4).Device evaluation: there are two files open for this complaint.For details of the first investigation reference complaint file 3001845648-2018-00285.The zisv6-35-80-6.0-100-ptx device of lot number c1479479 involved in this complaint was returned for evaluation without the original packaging.With the information provided, a physical examination and a document based investigation was conducted.Lab evaluation: the delivery system related to this occurrence underwent a laboratory evaluation on the 14 june 2018.The stent involved in this complaint was implanted in the patient and was not returned with the device and therefore, could not be evaluated during the lab evaluation.Document review: prior to distribution zisv6-35-80-6.0-100-ptx 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 (b)(4).A review of the manufacturing records for zisv6-35-80-6.0-100-ptx of lot number c1479479 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 c1479479.It may be noted that stent strut fracture is listed as a known potential adverse event within the instructions for use.Image review: images were provided to support the complaint investigation.They were reviewed through (b)(4) and the following comments were provided by the independent reviewer: impression: the complaint of a stretched stent secondary to reported retraction ribbon and retraction sheath separation is confirmed.No residual stenosis was present on completion angiography.Stent fracture where the stent was stretched is confirmed.Root cause review: a definitive root cause of stent fracture as a result of stretching on deployment was identified in the imaging review.Summary: complaint is confirmed as the failure was verified in the image(s).The stent was fractured where it was stretched on deployment.According to the initial reporter, in-stent stenting was required as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This file is related to 3001845648-2018-00285 which to address the initial event in (b)(6) 2018.This file addresses the stent fracture event which occurred 6 months later.The wire guide got torn off in delivery system."as per complaint form": after successful access to target lesion, vessel was pre-dilated.Then stent placement was started.The first part (ca.25-30%) of the stent could be released normally.But then stent got stuck; after further turning of the thumb wheel, there was no reaction and the internal wire seems to have broken.The stent could only be placed after pushing the sheath back and forth and manipulating it.In the end, the stent could be placed, but is partially damaged (photo only as printout, no digital version available; will be "send" with the returned device).All parts of the introducer system could be removed, but stent is still damaged and due to difficult placement elongated.New information (b)(6) 2018: rep reported that device had multiple stent fracture after 6 months.Cc form: in (b)(6) 2018 a complaint was logged.Now the patient came back with new problems.The angiography showed that this stent is now fractured several times.Dr.(b)(6) has done an instent-stenting with eluvia in the hope that the problem is solved.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8173125
• MDR Text Key: 130629426
• Report Number: 3001845648-2018-00603
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353104
• UDI-Public: (01)10827002353104(17)200228(10)C1479479
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: ZISV6-35-80-6.0-100-PTX
• Device Lot Number: C1479479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2018
• Event Location: Hospital
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2018
• 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