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

Model Number PRB35-08-040-120

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

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

The calcified iliac lesion was treated with atherectomy first.When the physician deployed the protege everflex stent, it "jumped" about 10 to 20 cm.We had to open another stent of the same size and deploy in the correct portion of the iliac.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.Additional information has been requested.Should it become available, a supplemental report will be submitted.

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.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM
• 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 north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 3881908
• MDR Text Key: 17259227
• Report Number: 2183870-2014-00140
• 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: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2016
• Device Model Number: PRB35-08-040-120
• Device Catalogue Number: PRB35-08-040-120
• Device Lot Number: 9707041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2013
• 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): Other