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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Fracture (1260)

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

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p100022/s100.This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for stent fracture, regardless of the patient outcome.The information received relating to this event is currently being investigated.Images were received to support the complaint investigation.A follow up report will be submitted once images have been reviewed with the investigation conclusions.This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for stent fracture, regardless of the patient outcome.The information received relating to this event is currently being investigated.Images were received to support the complaint investigation.A follow up report will be submitted once images have been reviewed with the investigation conclusions.

Event Description

On (b)(6) 2012: ziv6-35-125-6.0-120-ptx / lot c777371 x 2 + ziv6-35-125-7.0-120-ptx / lot c776221 x 1 were placed in the right sfa.On (b)(6) 2015: 3 year f/u confirmed a stent fracture (type ii) in the middle of one ziv6-35-125-6.0-120-ptx / c777371 placed in the upper right sfa.No further information has been provided.

Manufacturer Narrative

Pma/510(k) # p100022/s100.This complaint is reportable to the fda on the basis of the reporting precedence established for this product family for stent fracture, regardless of the patient outcome.This investigation addresses 1x ziv6-35-125-6.0-120-ptx of lot number c777371.The ziv6-35-125-6.0-120-ptx of lot number c777371 was implanted in the patient, therefore is not available for evaluation.With the information provided, a document based investigation was carried out.Images were available to support the complaint investigation.These were reviewed through med institute and the following comments in relation to stent fracture were provided by the independent reviewer: findings: two x-rays of the right thigh, one in the anterior posterior and the other in a left anterior oblique projection, are provided along with the complaint report.Three zilver ptx stent span the entire right superficial femoral artery.The entire stented length was 32cm.A supera stent was implanted inside the distal zilver stent at the adductor canal.The middle zilver stent obliquely angled twice creating a shallow zigzag configuration.At the proximal angulation, no definite excessive separation or overlap and no definite stent fractures were present.Distally the medial two adjacent stent rows completely overlapped at the inner apex of the distal angulation.Impression: without comparison to prior imaging and or high resolution, the presence of a type 2 mid stent fracture cannot be confirmed.The stent has a shallow zigzag configuration where presumably the fractures were believed to have occurred.The proximal angulation is indistinguishable from a shallow kink.The stent row overlap at the distal angulation most likely represents a type i fracture.According to comments provided a type ii fracture could not be identified, however, a type i stent fracture was most likely present at the distal angulation.Based on the images provided, a stent fracture (type i) was most likely present.It may be noted that stent strut fracture is a known potential adverse event associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.No adverse effects were experienced by the patient and no intervention was needed.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(6) 2012: ziv6-35-125-6.0-120-ptx / c777371 x 2 + ziv6-35-125-7.0-120-ptx / c776221 x 1 were placed in the right sfa.(b)(6) 2015: 3 year f/u confirmed a stent fracture (type ii) in the middle of one ziv6-35-125-6.0-120-ptx / c777371 placed in the upper right sfa.

• 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 ; EI
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 5073633
• MDR Text Key: 26489754
• Report Number: 3001845648-2015-00175
• Device Sequence Number: 1
• Product Code: NIU
• 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
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/06/2015
• Event Location: Hospital
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2012
• 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 Age: 83 YR