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

Catalog Number ZIV6-35-125-7-80-PTX

Device Problem Break (1069)

Patient Problems Surgery, prolonged (2177); Device Embedded In Tissue or Plaque (3165)

Event Date 03/13/2015

Event Type  Injury  

Event Description

The stent broke off inside the patient during delivery.Part of the stent was not retrieved and remained inside the patient's body and was stented over with a supera stent.No further adverse effects to the patient were reported.

Manufacturer Narrative

(b)(4).The info received relating to this event is currently being investigated.A f/u mdr will be submitted with the investigation conclusions.

• 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: sinead quaid, sr specialist ; 61334440
• MDR Report Key: 4770928
• MDR Text Key: 21928719
• Report Number: 3001845648-2015-00094
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2015
• Device Catalogue Number: ZIV6-35-125-7-80-PTX
• Device Lot Number: C1035830
• Other Device ID Number: (01)10827002248950(17)150313(1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• 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: 81 YR
• Patient Weight: 72