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

Catalog Number ZISV6-35-125-7.0-140-PTX

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation the zisv6-35-125-7.0-140-ptx device of lot number c1538810 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6) 2019.In the opened tyvek pouch, a hair was present and attached to the package with tape.Document review prior to distribution zisv6-35-125-7.0-140-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)(6).A review of the relevant manufacturing records ((b)(4)) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1538810.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0122-0).Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to operator error.Summary: complaint is confirmed as the failure was verified in the laboratory.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

A hair was found within the sterile packaging.Product didn't make contact with patient 2 as per complaint form"; when unpacking the product (transparent sterile packaging) a hair was spotted.The sister see the hair in the package and give the zptx to dr.(b)(6).He take the stent and want to insert it over the wire in the sheath (with blood contacted gloves).But no contact with the wire or the sheath.By the way and before the zptx-device-tip contact the wire and sheath, the sister tell about the hair and dr.(b)(6) stopped using the zptx.

• 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
• MDR Report Key: 9967701
• MDR Text Key: 202375186
• Report Number: 3001845648-2020-00246
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002354217
• UDI-Public: (01)10827002354217(17)200622(10)C1538810
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2020
• Device Catalogue Number: ZISV6-35-125-7.0-140-PTX
• Device Lot Number: C1538810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/22/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2018
• 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