MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-06-060-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review: two images have been provided showing the patient's leg with rash.The two photos are of the patient¿s lower leg.The patent¿s skin has tiny red dots in both pictures.
Event or Problem Description
Patient had bilateral iliac stents.3 in.Pact admiral balloon catheters were used to treat the lesion in the popliteal to popliteal/tibial trunk.Protege stent was implanted in the iliac artery to complete the procedure.Physician flipped patient over and accessed the popliteal artery to deliver the dcb into the sfa.Patient had just recently had shingles.Dr.(b)(6) was the physician that did the procedure but sales rep was contacted by dr.(b)(6) the following week.Patient had shingles prior to this but physician said the rash was different than the shingles.The sfa mid to distal was treated through popliteal access however no rash occurred on this portion of leg it was all distal to area treated.Patient was treated with steroids.Steroid was delivered orally steroid dose pack.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6489254
• Report Number: 2183870-2017-00165
• Device Sequence Number: 555442
• Product Code: FGE
• UDI-Device Identifier: 00821684069189
• UDI-Public: 00821684069189
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P060001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: 11/03/2018
• Device Catalogue Number: PRB35-06-060-120
• Device Lot Number: A183141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Other
• Patient Age: 57 YR