FDA Adverse Event Injury Summary report: N

PIPELINE EMBOLIZATION DEVICE

MDR report key: 2805305 · Received October 25, 2012

Report

Report Number: 2029214-2012-00562
Event Type: Injury
Date Received: October 25, 2012
Date of Event: April 17, 2012
Report Date: September 26, 2012
Manufacturer: EV3 NEUROVASCULAR
Product Code: OUT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. THESE ARE THE OTHER THREE PIPELINES THAT WERE USED IN THE PROCEDURE: MODEL#: FA-71500-30 (X2); LOT#: NOT REPORTED. MODEL#: FA-71500-35; LOT#: NOT REPORTED. (B)(4).

Description of Event or Problem · 1

INFORMATION FROM (B)(6) CLINICAL DATABASE. TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT MULTIPLE PIPELINES WERE IMPLANTED IN THE PATIENT WITHOUT ANY DIFFICULTIES. MULTIPLE MICRO WIRES WERE ALSO USED TO CROSS BACK THE ANEURYSM. THE LAST PIPELINE DEPLOYED PROXIMALLY, BUT IT HAD DIFFICULTY OPENING DISTALLY. THE PHYSICIAN DECIDED TO TRY TO RETRIEVE THE PIPELINE, BUT WITHOUT SUCCESS AND IT REMAINED IN THE PATIENT WITH DISTAL END STILL UN-OPENED. THE PATIENT HAD A SUB-ARACHNOID HEMORRHAGE (SAH) AND RUPTURED ANEURYSM LESS THAN A DAY POST PROCEDURE. A VENTRICULOSTOMY WAS PLACED IN THE PATIENT AND THE INTRACRANIAL (IA) CORPUS CALLOSUM LIPOMA (CCL) VERTEBRAL WAS SACRIFICED. THERE WERE MANY OTHER COMPLICATIONS AND PATIENT IS STILL ON A VENT AND A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. PATIENT REMAINS LARGELY NON-RESPONSIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PIPELINE EMBOLIZATION DEVICE	FLOW DIVERSION	OUT	EV3 NEUROVASCULAR	FA-77500-20 (X2)	NOT REPORTED

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR	Unknown	Disability