MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G38482
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
Additional 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.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.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 or Problem Description
As reported to customer relations, "mid-distal sfa intervention.The stent was deployed in normal fashion, but at some point the distal end of the stent was inverted or pulled back up into the stent.It appears the wire got entrapped in the stent, possibly.There was a large dissection distal to the stent.".
Event or Problem Description
As reported to customer relations, "mid-distal sfa intervention.The stent was deployed in normal fashion, but at some point the distal end of the stent was inverted or pulled back up into the stent.It appears the wire got entrapped in the stent, possibly.There was a large dissection distal to the stent.".
Additional 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.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: the zisv6-35-125-6-120-ptx device of lot number c1459144 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 zisv6-35-125-6-120-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 cirl.A review of the manufacturing records for zisv6-35-125-6-120-ptx of lot number c1459144 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 c1459144.It should be noted that the instructions for use states the following: ¿precautions a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment, and removal in order to ensure adequate support of the system.If hydrophilic wire guides are used, they must be kept fully activated.¿ 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 distal end of the stent was partially inverted and tapered.Because the stent was not deployed over a guidewire, it was deployed in a medial sfa dissection rather than in the lumen.The stent's inversion and tapering could have been caused by the dissection, wire entrapment during attempts to reenter the lumen, delivery system removal, and possibly balloon retrieval.Because the distal sfa dissection was not evident until after stent deployment and appeared secondary to angioplasty, it is possible a low profile balloon was successfully passed through the stent interstices.Balloon retrieval through the stent's interstices after angioplasty could have aggravated the stent's inversion.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the stent not being deployed over a wire guide.Summary: complaint is confirmed as the failure was verified in the image(s).The distal end of the stent was partially inverted and tapered.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.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8225834
• Report Number: 3001845648-2019-00007
• Device Sequence Number: 2112079
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)191123(10)C1459144
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2019
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C1459144
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention