MICRO DRIVER RX CORONARY STENT SYSTEM

MDR report key: 1032526 · Received April 22, 2008

Report

Report Number: 2953200-2008-00238
Event Type: Injury
Date Received: April 22, 2008
Date of Event: February 15, 2007
Report Date: March 25, 2008
Manufacturer: MEDTRONIC CARDIOVASCULAR GALWAY
Product Code: MAF
PMA / PMN Number: P030009
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: RESULTS AND CONCLUSIONS: (LACK OF INFORMATION, NO FILMS RECEIVED).

Description of Event or Problem · 1

A 2.75 MM DIAMETER X 12 MM LENGTH MICRO DRIVER RX CORONARY STENT SYSTEM WAS IMPLANTED INTO A PATIENT FOR TREATMENT OF AN IMPENDING OCCLUSION IN A TYPE A LAD LESION. THE LESION MORPHOLOGY WAS NOT TORTUOUS NOR CALCIFIED WITH A 90% STENOSIS PRE-STENT DEPLOYMENT. IT WAS REPORTED THAT THE STENT WAS DEPLOYED SUCCESSFULLY WITH REMAINING STENOSIS AT 18%. FIVE DAYS LATER THROMBOSIS OCCURRED IN THE DEPLOYED STENT. A 2.5 MM X 14 MM MICRO DRIVER RX STENT WAS SUCCESSFULLY IMPLANTED WITHIN THE PREVIOUSLY DEPLOYED 2.75 X 12 MICRO DRIVER STENT TO TREAT THE THROMBOSIS. AT THE 30 DAY AND NINE MONTH FOLLOW UPS THERE WAS NO ANGINA PECTORIS REPORTED. THE PHYSICIAN REPORTED THAT STENT THROMBOSIS HAD CAUSATION WITH THE DEPLOYED STENT AS THERE WAS A POSSIBILITY OF CAUSATION BETWEEN THE STENT THROMBOSIS AND PCI PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. 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	MICRO DRIVER RX CORONARY STENT SYSTEM		MAF	MEDTRONIC CARDIOVASCULAR GALWAY	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention