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

Catalog Number ZIV6-35-125-7-100-PTX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Surgery, prolonged (2177)

Event Date 07/02/2014

Event Type  Injury  

Event Description

(b)(4); study pt (b)(6).Procedure was the left distal sfa, with mild calcification, tasc i type b, 3 prov lesion was 60 mm in length.On the day of the procedure, per ae form of study "there was a new cutoff in the mid peroneal artery, which reconstituted via strong collaterals in the distal segment." treatment included thrombectomy.The pt was discharged the same day.The study site has indicated the device did not malfunction or deteriorate in characteristics or performance.The study site has also indicated that this ae event was possible related to the device, but most definitely related to the study procedure.

Manufacturer Narrative

Pma/510(k)#: s001.(b)(4).No device malfunction has been reported.However intervention (thrombectomy) was performed during the procedure.The user has indicated that this ae was possibly related to the device but most definitely related to the procedure.Adopting a conservative approach this event will be mdr reported to the fda based on use of the device leading to surgical intervention.The device involved in this complaint is ziv6-35-125-7-100-ptx, lot number c979743.The stent was implanted int he pt and therefore is not available for return/evaluation.With the information provided a document based investigation was carried out.As the device was not available for evaluation and the conditions of use cannot be replicated in a laboratory setting it is not possible to determine a root cause for this complaint.As per information received, the device did not malfunction or deteriorate in characteristics or performance.The pt was discharged on the same day.From the information provided it is more likely that the ae injury reported for this complaint was caused due to the study procedure and not due to the ptx stent.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 for zilver ptx and zilver ptx drug eluting stent revealed no discrepancies that could have contributed to this complaint.The complaint is confirmed based on customer testimony.Quality engineering will continue to monitor complaints of this nature 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; limerick ; EI
• Manufacturer Contact: tracy o'sullivan, unk ; 61334440
• MDR Report Key: 4203303
• MDR Text Key: 16175695
• Report Number: 3001845648-2014-00203
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: ZIV6-35-125-7-100-PTX
• Device Lot Number: C979743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2014
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 53 YR