ENDEAVOR SPRINT RX

MDR report key: 5387814 · Received January 25, 2016

Report

Report Number: 9612164-2016-00084
Event Type: Death
Date Received: January 25, 2016
Date of Event: December 5, 2015
Report Date: December 28, 2015
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P060033
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DATE OF DEATH - DATE IS APPROXIMATE.

Description of Event or Problem · 1

IT WAS INTENDED TO USE AN ENDEAVOR SPRINT DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION IN THE LAD. THE LESION HAD ALMOST 100 % STENOSIS AND TIMI GRADE 0. THE PATIENT ALSO HAD 50-70% STENOSIS IN THE PROXIMAL-MIDDLE LCX, 60% STENOSIS IN THE MIDDLE OF RGA, AND 70% STENOSIS IN THE DISTAL OF PDA, TIMI GRADE 3. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.0 X 15 MM BALLOON AT A PRESSURE OF 12-16ATM. THE ENDEAVOR STENT WAS IMPLANTED AT A PRESSURE OF 12 ATM, HOWEVER THE STENT WAS ONLY PARTIALLY EXPANDED. THE PHYSICIAN THEN DILATED THE STENT USING A BALLOON AT 16-22 ATM. A VESSEL DISSECTION WAS THEN NOTED AT THE DISTAL OF THE STENT. THE PHYSICIAN THEN IMPLANTED A SECOND ENDEAVOR SPRINT STENT DISTALLY, AT 10 ATM. THE SECOND STENT WAS POST DILATED. THE STENT WAS COMPLETELY ADHERENT TO THE WALL, WITH NO RESIDUAL STENOSIS. THE PATIENT SUBSEQUENTLY EXPIRED DUE TO STENT THROMBOSIS - THE PHYSICIAN DETERMINED THAT THROMBUS CAUSED PATIENT'S DEATH AND THE EVENT WAS RELATED TO THE PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
47433	ENDEAVOR SPRINT RX	STENT, CORONARY, DRUG-ELUTING	NIQ	MEDTRONIC IRELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	00051 YR		Death\| R