COMPLETE SE ILIAC

MDR report key: 2880801 · Received December 20, 2012

Report

Report Number: 9612164-2012-01804
Event Type: Malfunction
Date Received: December 20, 2012
Date of Event: November 27, 2012
Report Date: November 28, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: NIO
PMA / PMN Number: P090006
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION RESULTS AND CONCLUSION: (PATIENT LESION MORPHOLOGY, SEVERE CALCIFICATION AND 90% STENOSIS). (B)(4).

Description of Event or Problem · 1

THE PHYSICIAN WAS ATTEMPTING TO DEPLOY AN 8MM DIAMETER X 40MM LENGTH COMPLETE SELF EXPANDING (SE) PERIPHERAL BARE METAL STENT SYSTEM TO TREAT A LESION IN THE SFA OF A PATIENT THAT WAS PRE-DILATED AND REPORTED TO HAVE SEVERE CALCIFICATION AND 90% STENOSIS. IT WAS REPORTED THAT WHILE PLACING THE STENT IN THE SFA AND WHILST RETRIEVING THE STENT SYSTEM, THE STENT COLLAPSED DISTALLY. A SECOND STENT WAS REQUIRED AND DEPLOYED INSIDE THE FIRST STENT. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THERE WAS NO DAMAGE OR DEFORMATION EVIDENT TO THE DELIVERY SYSTEM. THE DISTAL AND PROXIMAL INNER SHAFT MARKERS WERE PRESENT AND THE DISTAL TIP WAS INTACT. .

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COMPLETE SE ILIAC	STENT, ILIAC	NIO	MEDTRONIC IRELAND		0006183773

Patients

Seq	Age	Sex	Outcome	Treatment
1	00058 YR		Required Intervention