FDA Adverse Event Malfunction Summary report: N

APEX?

MDR report key: 3781087 · Received April 30, 2014

Report

Report Number: 2134265-2014-02314
Event Type: Malfunction
Date Received: April 30, 2014
Date of Event: April 2, 2014
Report Date: April 2, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR ID: 2134265-2014-02315 AND 2134265-2014-02317. IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN AN UNSPECIFIED DATE, A 3.0 X 12 TAXUS LIBERTE STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. IN (B)(6) 2014, THE PATIENT PRESENTED WITH ST ELEVATIONS AND RESTENOSIS. THE PHYSICIAN WENT ON TO BALLOON THE VESSEL. THE FIRST BALLOON USED WAS A 2.50MM X 15MM APEX CATHETER BALLOON WHICH WAS ADVANCED TO THE LESION. THE BALLOON WAS INFLATED AND ON FIRST INFLATION IT RUPTURED AT 6 ATMOSPHERES (ATMS). THE SECOND BALLOON USED WAS A 2.25MM X 15MM APEX CATHETER BALLOON WHICH WAS ADVANCED TO THE LESION AND ON FIRST INFLATION ALSO RUPTURED AT 6 ATMS. THE 2 DEVICES WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON AND PLACEMENT OF A 3.0X16MM PROMUS PREMIER STENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259907	APEX?	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493895915250	16812188

Patients

Seq	Age	Sex	Outcome	Treatment
1