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

Model Number	EVD35-08-060-080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had a dissected femoral artery during a st-elevation myocardial infarction (stemi) which required the implantation of a non-medtronic coronary stent and 2 everflex entrust stents in the iliacs.It was reported there was no allergy or symptoms present during the patient¿s stay at the facility where the stents were implanted.However, months post the reported procedure, the patient was experiencing some type of allergic reaction.A slight rash and skin discoloration were reported.The patient has been provided with all of the stent names and metals associated with the everflex stents.The patient has reported attending a dermatologist and has reported having a biopsy carried out on the rash.The results of the biopsy have not yet been reported.It is not known if the patient received any treatment for the reported rash.
Additional Manufacturer Narrative
A non-medtronic coronary stent was implanted at the same time as the 2 everflex entrust stents were implanted in the iliacs.There was no allergy or symptoms present during the patient¿s stay at the facility where the stents were implanted.It was reported that the stents were implanted by (b)(6), at (b)(6) medical center, in (b)(6).The allergic reaction was reported to have occurred months post procedure to another physician.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7951617
• Report Number: 2183870-2018-00460
• Device Sequence Number: 428424
• Product Code: NIP
• UDI-Device Identifier: 00821684051283
• UDI-Public: 00821684051283
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: EVD35-08-060-080
• Device Catalogue Number: EVD35-08-060-080
• Device Lot Number: A597448
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 78