FDA Adverse Event Malfunction Summary report: N

NEUROFORM MICRODELIVERY STENT SYSTEM

MDR report key: 805647 · Received January 3, 2007

Report

Report Number: 6000078-2007-00004
Event Type: Malfunction
Date Received: January 3, 2007
Date of Event: November 9, 2006
Report Date: December 6, 2006
Manufacturer: NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
Product Code: NJE
PMA / PMN Number: H020002/s4
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IN QUESTION HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND/ OR SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADDITIONAL 510K# H020002/S5.

Description of Event or Problem · 1

THE PHYSICIAN REPORTED HE WAS PERFORMING NEUROVASCULAR ENDOTHERAPY PROCEDURE. THE PORTS OF THE STENT SYSTEM WERE PROPERLY IRRIGATED DURING PREP BEFORE THE PROCEDURE. THE PHYSICIAN REPORTED HE POSITIONED THE STENT IN THE ANATOMICAL POSITION HE WANTED AND REPORTEDLY NOTICED RESISTANCE WHEN MANIPULATING THE STABILIZER. IT WAS AT THAT TIME THE PHYSICIAN REPORTED HE MADE THE DECISION NOT TO CONTINUE TRYING TO LIBERATE THE STENT, BUT TO WITHDRAW IT COMPLETELY. THE PHYSICIAN REPORTED "DURING THE ATTEMPT TO WITHDRAW THE STENT, IT WAS DEPLOYED SPONTANEOUSLY IN A PLACE DIFFERENT FROM THE ANATOMICAL TARGET WITHOUT PUTTING THE PATIENT AT RISK." THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THE PHYSICIAN REFUSED TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEUROFORM MICRODELIVERY STENT SYSTEM	(NJE) INTRACRANIAL STENT	NJE	NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION	E340020	8823314

Patients

Seq	Age	Sex	Outcome	Treatment
1	*