MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number PRB35-06-060-120

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

Patient Problem Erythema (1840)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).

Event Description

This patient was part of the durability post approval study.Two stents were deployed in the target lesion (b)(6) 2015.The target area was the left sfa.According to the source, the second stent listed was placed in the upper (proximal) sfa lesion in the upper portion of the thigh and the other was placed distally over a total occlusion.The distal stent was at the terminus of the proximal stent, so there is no gap between the two.Per source documents, "both stents opened up very nicely." however, there was right groin pain that was indurated and erythematous, along with a right groin wound.Bedside incision, iv antibiotics, and drainage of the wound were performed.The event was noted as resolved on (b)(6) 2015.The right common femoral was normal in course and caliber.Per source this event is related to the index procedure, but not related to study device or requirements.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane n; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5287915
• MDR Text Key: 33255487
• Report Number: 2183870-2015-07574
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: PRB35-06-060-120
• Device Catalogue Number: PRB35-06-060-120
• Device Lot Number: A128278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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: 00069 YR