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

Catalog Number ZISV6-35-125-6-80-PTX

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s014.(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 device did not deploy.Opened a 2nd zisv6-35-125-6-80-ptx and it deployed successfully to complete the procedure." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.No adverse effects to the patient have been reported as occurring.

Event Description

As reported to customer relations, "the device did not deploy.Opened a 2nd zisv6-35-125-6-80-ptx and it deployed successfully to complete the procedure." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.No adverse effects to the patient have been reported as occurring.

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 zisv6-35-125-6-80-ptx device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.A number of attempts were made to obtain additional information in relation to this event.However, at the time of the investigation, a response had not been received.The investigation will be updated if any additional information regarding the details of this event is provided to cirl in the future.Lab evaluation ¿ n/a document review as the lot number of the complaint stent is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6-35-125-6-80-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.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.From the information provided it is known that the device was advanced via contralateral approach.It is possible that if the patient¿s anatomy was difficult and the bifurcation angle was tight, there may have been resistance during advancement and/or attempted deployment.It is possible that this resistance resulted in the inability to deploy the stent.However, as no additional information was received and as the device was not returned for evaluation, a conclusive root cause cannot be determined.Summary the complaint is confirmed based on customer testimony.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: 8715444
• MDR Text Key: 150146482
• Report Number: 3001845648-2019-00275
• Device Sequence Number: 1
• Product Code: NIU
• 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: 06/20/2019

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 Catalogue Number: ZISV6-35-125-6-80-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1