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

Catalog Number ZIV6-35-125-6-100-PTX

Device Problem Occlusion Within Device (1423)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Surgical procedure, additional (2564)

Event Date 11/26/2014

Event Type  Injury  

Event Description

The patient had a zilver ptx 35 drug-eluting stent implanted on (b)(6) 2014.On (b)(6) 2014 the patient had severe pain over the site of the stent, followed by (b)(6) the patient presented with a wound right through the skin (necrotizing cellulitis).Open surgery was performed to remove the occluded and infected stent.It is unknown at this time the condition of the patient and patient follow up will determine if/when the patient will need the sfa bypassed.Additional complaint details have been requested.The information received relating to this event is currently being investigated.A follow up mdr will be submitted with the investigation conclusions.

Manufacturer Narrative

Pma/510(k)#:p100022 and s001.(b)(4).The information received relating to this event is currently being investigated.A follow up 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, ; 61334440
• MDR Report Key: 4370141
• MDR Text Key: 17294294
• Report Number: 3001845648-2014-00341
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2015
• Device Catalogue Number: ZIV6-35-125-6-100-PTX
• Device Lot Number: C1006841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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: 59 YR