ENDEAVOR RX

MDR report key: 1031173 · Received April 18, 2008

Report

Report Number: 2953200-2008-00229
Event Type: Injury
Date Received: April 18, 2008
Date of Event: December 18, 2007
Report Date: February 22, 2008
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: NIQ
PMA / PMN Number: P060033
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

RESULTS- INHERENT RISK OF PROCEDURE (MYOCARDIAL INFARCTION). OTHER, (LACK OF INFO).

Description of Event or Problem · 1

PT HAD BEEN TREATED FOR HYPERTENSION. TWO LESION WERE TREATED 20 MONTHS AGO. MEDICATIONS PRESCRIBED AT THE DAY OF PROCEDURE WERE AS FOLLOWS: ASPIRIN - 100MG. THE FIRST LESION TREATED WAS LOCATED IN THE PROXIMAL RCA. ONE BARE METAL STENT (BRAND UNK - NOT REPORTED) WAS SUCCESSFULLY IMPLANTED. THE SECOND LESION TREATED WAS LOCATED IN THE DIAGONAL LAD. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED (2.75X12MM). AT 30 DAY FOLLOW UP, PT WAS PRESCRIBED 250MG TICLOPIDINE. AT MONTH FOLLOW TICLOPIDINE WAS STOPPED AND 75MG CLOPIDOGREL WAS PRESCRIBED. PT SUFFERED NON-Q-WAVE MYOCARDIAL INFARCTION ON 16 MONTHS POST IMPLANT AND AS A RESULT, IT WAS REPORTED THAT REVASCULARIZATION (PTCA) WAS PERFORMED ON THE SAME DAY. THE LOCATION OF THE REVASCULARIZATION WAS THE DIAGONAL LAD VESSEL (TARGET LESION, TARGET VESSEL). THE INVESTIGATOR STATED THAT THE RELATIONSHIP BETWEEN THE REVASCULARIZATION EVENT AND THE ENDEAVOR STENT WAS DEFINITIVE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDEAVOR RX		NIQ	MEDTRONIC CARDIOVASCULAR GALWAY	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention