FDA Adverse Event Malfunction Summary report: N

NEXSTENT MONORAIL

MDR report key: 1002089 · Received February 20, 2008

Report

Report Number: 2134265-2008-00493
Event Type: Malfunction
Date Received: February 20, 2008
Date of Event: January 25, 2008
Report Date: January 25, 2008
Manufacturer: BOSTON SCIENTIFIC
Product Code: NIM
PMA / PMN Number: P050025
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

SAME CASE AS 2134265-2008-00494. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTY WAS EXPERIENCED. THE PHYSICIAN WAS TREATING THE INTERNAL CAROTID/BIFURCATION. WHEN DISCUSSING AFTER THE CASE WAS FINISHED, THE PHYSICIAN STATED WHEN HE PULLED THROUGH THE SHEATH, THERE WAS RESISTANCE. THEY WERE ABLE TO PLACE THE NEXSTENT IN THE BIFURCATION INTERNAL CAROTID, BUT IT WAS DIFFICULT TO TRACK IT BACK INTO THE REMOVAL SHEATH. THE PHYSICIAN HAD TO PULL IT ALL OUT AT ONCE AND FOUND THE PROBLEM WAS THE DISTAL TIP OF THE DELIVERY SYSTEM CAME OFF AND WAS LODGE IN THE (FILTERWIRE) SHEATH MAKING IT UNABLE TO PULL BAG AND CLOSE. FILTERWIRE WAS UNABLE TO BE RE-CAPTURED DUE TO THE TIP OF THE STENT. IT WAS SITTING IN THE BASKET OF THE FILTER. IT WAS NOTICED UNTIL THE SYSTEM WAS REMOVED. THERE WERE NO COMPLICATIONS AND THE PT CONDITION IS LISTED AS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEXSTENT MONORAIL	NIM STENT, CAROTID	NIM	BOSTON SCIENTIFIC	NA	C71302

Patients

Seq	Age	Sex	Outcome	Treatment
1