FDA Adverse Event Malfunction Summary report: N

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1032601 · Received April 22, 2008

Report

Report Number: 2134265-2008-01151
Event Type: Malfunction
Date Received: April 22, 2008
Date of Event: March 24, 2008
Report Date: March 26, 2008
Manufacturer: BOSTON SCIENTIFIC
Product Code: NIQ
PMA / PMN Number: P030025
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

SAME CASE AS 2134265-2008-01152. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE LESION WAS PRE-DILATED WITH SEVERAL MAVERICK MONORAIL BALLOONS, UNKNOWN SIZES. THE PHYSICIAN ATTEMPTED TO PLACE A TAXUS EXPRESS2 3.5 X 12 MM DRUG ELUTING STENT TO THE EXTREMELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, AT AN ACUTE ANGLE, BUT WAS UNABLE TO CROSS THE LESION. WHILE PUSHING AND PULLING IN AN ATTEMPT TO CROSS THE LESION, THE SHAFT BROKE NEAR THE PROXIMAL PORTION OF THE DEVICE. ANOTHER ATTEMPT WAS MADE WITH A TAXUS EXPRESS2 3.5 X 8 MM DRUG ELUTING STENT, BUT AGAIN A SHAFT FRACTURE OCCURRED WHILE ATTEMPTING TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY, UNKNOWN TYPE AND SIZE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM	NIQ STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC	3.5X12MM	0011074212

Patients

Seq	Age	Sex	Outcome	Treatment
1