PIPELINE EMBOLIZATION DEVICE

MDR report key: 2924228 · Received January 22, 2013

Report

Report Number: 2029214-2013-00075
Event Type: Injury
Date Received: January 22, 2013
Date of Event: December 21, 2012
Report Date: December 23, 2012
Manufacturer: EV3 NEUROVASCULAR
Product Code: OUT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM CLOTTED IN THE CENTER OCULAR SYMPTOMS. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT A STENOSIS DISTAL OF THE ANEURYSM NECK MADE THE PIPELINE DIFFICULT TO DEPLOY. THE PHYSICIAN STATED THAT THEY COULD NOT SEE ANYTHING BEFORE AND DURING THE PROCEDURE, BUT THE PIPELINE WAS NOT FULLY OPEN IN THE MIDDLE. THEY TRIED TO REMOVE THE ENTIRE SYSTEM, BUT IT WAS IMPOSSIBLE TO PUSH THE DELIVER WIRE FORWARD. AT THE END OF THE PROCEDURE, THE CONTRAST STAYED IN THE ANEURYSM SAC AND EVERYTHING WAS FINE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
29678	PIPELINE EMBOLIZATION DEVICE	FLOW DIVERSION	OUT	EV3 NEUROVASCULAR	FA-71425-30	9541542

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Disability