ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

Report

Report Number: 9612164-2011-00071
Event Type: Injury
Date Received: March 16, 2011
Date of Event: February 18, 2011
Report Date: February 18, 2011
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P060033
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: MI, TVR.

Description of Event or Problem · 1

IT WAS CONFIRMED THAT DURING THE REVASCULARIZATION ON THE SAME DAY AS THE REPORTED MI THERE WERE TWO UNKNOWN BRAND STENTS IMPLANTED IN THE VEIN GRAFT OFF THE 1ST DIAGONAL BRANCH TO TREAT VEIN GRAFT STENOSIS.

Description of Event or Problem · 1

DURING THE INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT OVER-THE-WIRE (OTW) STENTS IMPLANTED TO THE PROXIMAL LCX AND ONE ENDEAVOR SPRINT OTW STENT IMPLANTED TO THE LEFT MAIN. TWO DAYS POST INDEX PROCEDURE THE PATIENT IS REPORTED TO HAVE SUFFERED A MYOCARDIAL INFARCTION (NON-ST SEGMENT ELEVATION). THE INVESTIGATOR ASSESSED THAT THE TARGET LESION WAS NOT INVOLVED. THE PATIENT WAS SCHEDULED TO UNDERGO A STAGED PROCEDURE TO THE LAD. THE PHYSICIAN COULD NOT PASS THE TORTUOUS VEIN GRAFT TO REACH THE LAD AND A STENT WAS PLACED IN THE VEIN GRAFT. WHILE ATTEMPTING TO PROCEED THE LAD A PERFORATION IS REPORTED TO HAVE OCCURRED. THE PERFORATION SPONTANEOUSLY SEALED AND THE REST OF THE PROCEDURE WAS STOPPED. THE INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE OR STUDY DRUG. THE PATIENT RECOVERED WITH TREATMENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED. REF MFR REPORT NUMBER 9612164-2011-00072.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM		NIQ	MEDTRONIC IRELAND	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	82 YR	Male	Required Intervention	CLOPIDOGREL\| ASPIRIN