MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLX; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number PRB35-06150120

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

Patient Problem Vascular Dissection (3160)

Event Date 02/26/2015

Event Type  Injury  

Event Description

This procedure was part of the (b)(4) study.The subject became hypotensive due to a dissection of the left common artery.Aortic cuff and bilateral iliac kissing stents were placed.The dissection and subsequent hypotension were resolved.Per the site, this was related to the study procedure, unrelated to the study components.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.Additional correction.

• Brand Name: PROTEGE EVERFLX
• 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 north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4682000
• MDR Text Key: 5688774
• Report Number: 2183870-2015-00139
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2017
• Device Model Number: PRB35-06150120
• Device Catalogue Number: PRB35-06150120
• Device Lot Number: A013692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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: 74 YR