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

Model Number G38482

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "the doctor was deploying the device backwards and after 3 clicks, the device just stopped and the stent did not deploy.The complaint device was removed and a new g38482-zisv6-35-125-6-120-ptx was opened and used to complete the procedure successfully.".

Event Description

As reported to customer relations, "the doctor was deploying the device backwards and after 3 clicks, the device just stopped and the stent did not deploy.The complaint device was removed and a new g38482-zisv6-35-125-6-120-ptx was opened and used to complete the procedure successfully.".

Manufacturer Narrative

510 (k) number; 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 c1508813 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 10th january 2019.Crinkling was observed on the stent retraction sheath (srs) and the retraction wire was separated from the srs.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 c1508813 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 c1508813.There is no evidence to suggest that the customer did not follow the instructions for use.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 difficult patient anatomy and/or bending of the delivery system.Crinkling was observed on the stent retraction sheath (srs) during the lab evaluation suggesting the patient¿s anatomy may have been somewhat tortuous.It is possible that this caused and/or contributed to greater strain on the device during deployment resulting in separation of the retraction wire from the srs.It is also possible that the system was coiled or bent causing strain resulting in separation of the retraction wire from the srs during attempted deployment.Summary: complaint is confirmed as the failure was verified in the laboratory.The retraction wire was separated from the srs which would have disrupted the deployment mechanism preventing complete stent deployment.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
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8211406
• MDR Text Key: 131917811
• Report Number: 3001845648-2018-00616
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)200417(10)C1508813
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2020
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C1508813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/31/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR