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

Model Number	G38481
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypovolemia (2243); Disability (2371)
Date of Event	10/02/2018
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.Device evaluation: the zisv6-35-125-6-100-ptx device of lot number c1537950 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.There was 5 cook stents involved in this event.Reference (b)(4)(2 stents), (b)(4) (1 stent), (b)(4)(1 stent), (b)(4)(1 stent).Document review: prior to distribution all zilver zisv6 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (c1537950) revealed no discrepancies that could have contributed to this complaint.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1537950.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: this event of the patient undergoing amputation post stent placement was likely not stent related.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The patient did undergo amputation which was likely not stent related.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
On (b)(6) 2018 an arteriogram of the lower leg with balloon angioplasty and stent placement was performed and 5 cook stents were placed.No flow was noted, and the physician indicated they did not believe it was due to the devices.On (b)(6) 2019 the dm followed up to check on the patient, and the physician informed the dm that the patient had to have amputation (unknown location).Patient is stable and healing well.

• 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: 8339344
• Report Number: 3001845648-2019-00062
• Device Sequence Number: 16678580
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)200503(10)C1537950
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/03/2020
• Device Model Number: G38481
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: C1537950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2019
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/14/2019
• 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: Disability