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

Model Number G38481

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypovolemia (2243); Disability (2371)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # = p100022/s014.(b)(4).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 pr252461 (2 stents), pr253168 (1 stent), pr253170 (1 stent), pr253171 (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 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
• 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: 8339344
• MDR Text Key: 136141760
• Report Number: 3001845648-2019-00062
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)200503(10)C1537950
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2019
• Event Location: Home
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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): Disability