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

Catalog Number ZIC6-35-125-6.0-120-PTX

Device Problem Fracture (1260)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

(b)(6) 2012, two zilver ptx stents, ziv6-35-125-6.0-120-ptx/c778923 & ziv6-35-125-6.0-120-ptx/c775583 were placed from the right sfa to the pop a/ (above-the-knee).On (b)(6) 2014: x-ray image confirmed that the stent place din the distal side was fracture (type iii).As of (b)(6) 2014, no additional treatment has been secured.There have been no adverse effects to the patient reported.The lot number of the fractured stent is either c778923 or c775583., but cannot be determined.Therefore a report has bee submitted for both suspected lots.Reference also mdr report ref #3001845648-2014-00232.

Manufacturer Narrative

Pma/510(k): p100022 and s001.Udi#: (b)(4).Incident meets the reporting criteria of an fda mdr report based on the reporting precedence established for this device family for stent fracture regardless of patient outcome.The ziv6-35-125-6.0-120-ptx stent of lot number c775583 was implanted in the patient is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation and were reviewed as follows: findings: x-ray images of the distal proximal stent and the majority of the distal stent were provided.These images were photographed from ma computer monitor.Of the four provided images, two were side-by-side images of the stent at different dates.Three areas of the distal stent are suspicious but not definite for fracture.These areas are labelled area 1, 2, and 3 on the provided images.Area 1 suggests at least some stretching.Increased density in area 2 is at least in part superimposed calcified atheroma but also could represent fractured and now overlapping stent struts.Area 3 is the only portion of the stent that has significantly changed between (b)(6) 2014.Here an oblique lucency has developed at a point of slight stenosis and direction change.Verification of stent fracture is impossible.The only definite conclusion is that lumen compromised by a type iv stent fracture was not present.Impression: the provided imaging suggests development of an oblique stent fracture associated with twisting in the region of the adductor canal.Image quality was insufficient to verify.Stent fracture from twisting and stretching risk was greatest at and just inferior and adductor canal (j vasc interv radiol (b)(6) 2010): 195-202).Based on the images, the customer complaint was confirmed as provided imaging suggests stent fracture associated with twisting in the region of the adductor canal.However, stent fracture cannot be definitely confirmed as image quality was insufficient to verify.See scanned page.

• Brand Name: ZILER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. regulatory aff ; 61334440
• MDR Report Key: 4260743
• MDR Text Key: 20292593
• Report Number: 3001845648-2014-00233
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: ZIC6-35-125-6.0-120-PTX
• Device Lot Number: C775583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2012
• 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