MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZIV6-80-14-8.0

Device Problem Fracture (1260)

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

Event Date 10/12/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Post deployment balloon dilation showed fracture of the stent.

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Post deployment balloon dilation showed fracture of the stent.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as another stent was placed within the fractured stent also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.

Event Description

Post deployment balloon dilation showed fracture of the stent.

Manufacturer Narrative

Pma/510(k)#: p050017/s002 and s003.Device evaluation: the ziv6-80-14-8.0 device of lot number: c1557651 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation: n/a-device did not return.Document review: prior to distribution ziv6-80-14-8.0 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 relevant manufacturing records (c1557651) 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 c1557651.There is evidence to suggest that the customer did not follow the instructions for use (ifu0041-7).¿this product is intended for use in the iliac arteries¿.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to off label use, as the device was used in the biliary system.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, a second stent was placed inside the fractured stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9294850
• MDR Text Key: 165549371
• Report Number: 3001845648-2019-00583
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002372914
• UDI-Public: (01)10827002372914(17)211115(10)C1557651
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2021
• Device Catalogue Number: ZIV6-80-14-8.0
• Device Lot Number: C1557651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/12/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/14/2019; 10/14/2019
• Supplement Dates FDA Received: 12/06/2019; 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention