PIPELINE EMBOLIZATION DEVICE

MDR report key: 3001737 · Received March 13, 2013

Report

Report Number: 2029214-2013-00214
Event Type: Injury
Date Received: March 13, 2013
Date of Event: December 20, 2011
Report Date: February 22, 2013
Manufacturer: EV3 NEUROVASCULAR
Product Code: OUT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4)

Additional Manufacturer Narrative · 1

THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL: FA-77475-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71500-35 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-71500-30 / LOT: NOT REPORTED / DOM: N/A / EXP: N/AMODEL: FA-77500-20 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A(B)(4).

Description of Event or Problem · 1

INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED FUSIFORM ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 26MM X 12MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION INVOLVING FIVE PIPELINES. THE FIFTH PIPELINE WAS DEPLOYED AT A STENOTIC SEGMENT IN THE LEFT CAV (CAVERNOUS) ICA (INTERNAL CAROTID ARTERY) PROXIMAL TO THE ANEURYSM NECK. BALLOON ANGIOPLASTY WAS DONE ON THIS PIPELINE TO REDUCE THE STENOSIS AND ACHIEVE FULL WALL APPOSITION. EIGHT DAYS AFTER THE PROCEDURE, THE PATIENT HAD APHASIA AND A LEFT FRONTAL LOBE IPSILATERAL INTRACRANIAL HEMORRHAGE. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2011, BUT FOLLOW-UP ON (B)(6) 2012 REVEALED A LEFT 6TH CRANIAL NERVE PALSY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105520	PIPELINE EMBOLIZATION DEVICE	FLOW DIVERSION	OUT	EV3 NEUROVASCULAR	FA-71450-35	NOT REPORTED

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Required Intervention\| S