PIPELINE EMBOLIZATION DEVICE

MDR report key: 2924229 · Received January 22, 2013

Report

Report Number: 2029214-2013-00063
Event Type: Injury
Date Received: January 22, 2013
Date of Event: January 2, 2013
Report Date: January 2, 2013
Manufacturer: EV3 NEUROVASCULAR
Product Code: OUT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
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).

Description of Event or Problem · 1

TREATMENT OF A LEFT UNRUPTURED OPHTHALMIC FUSIFORM ANEURYSM MEASURING 17MM X 9MM. POST PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE MARKSMAN CATHETER IN ORDER TO RETRIEVE THE PUSHWIRE, BUT THE PIPELINE WAS PUSHED AND HERNIATED INTO THE ANEURYSM. MANY FAILED ATTEMPTS WERE MADE TO MANIPULATE AND/OR RETRIEVE THE DEVICE WITH A SNARE. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE POST PROCEDURE, BUT THEN EXPERIENCED AN IPSILATERAL STROKE TO THE FRONTAL LOBE WITH SOME SPEECH DEFICITS. UPON FURTHER TESTING, THE PATIENT WAS DISCOVERED TO BE NOT RESPONDING WELL TO PLAVIX.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
31104	PIPELINE EMBOLIZATION DEVICE	FLOW DIVERSION	OUT	EV3 NEUROVASCULAR	FA-71375-20	9614917

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention\| S