FDA Adverse Event Injury Summary report: N

MATRIX DETACHABLE COILS

MDR report key: 1693876 · Received May 19, 2010

Report

Report Number: 2939204-2010-00278
Event Type: Injury
Date Received: May 19, 2010
Report Date: March 22, 2006
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: HCG
PMA / PMN Number: UNKNOWN
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ES
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA # OR 510 K #: K012985 AND K031168. ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT SUFFERED NO CLINICAL CONSEQUENCES. A REVIEW OF THE LABELING FOUND THAT THE DIRECTIONS FOR USE NOTES THAT MULTIPLES PROCEDURES MAYBE REQUIRES TO COMPLETELY OCCLUDE AN ANEURYSM. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION

Description of Event or Problem · 1

IT WAS REPORTED THAT UPON FOLLOW UP THE TWO PREVIOUSLY TREATED ANEURYSMS SHOWED RECANALIZATION. THE PATIENT WAS RETREATED, DATE OF THE SECOND EMBOLIZATION PROCEDURE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MATRIX DETACHABLE COILS	DEVICE, NEUROVASCULAR EMBOLIZATION	HCG	BOSTON SCIENTIFIC - CORK	UNK536

Patients

Seq	Age	Sex	Outcome	Treatment
1	28 YR		Required Intervention	(B) (4) - MATRIX SOFT 2D SR\| (B) (4) - MATRIX FIRM 2D\| (B) (4) - MATRIX 360 SR\| (B) (4) - MATRIX STANDARD 3D\| (B) (4)0 - MATRIX SOFT 2D SR\| (B) (4) - MATRIX2 SOFT 360 SR\| (B) (4) - MATRIX FIRM 3D\| (B) (4) - MATRIX FIRM 3D\| (B) (4) - MATRIX SR 2D\| (B) (4) - MATRIX FIRM 3D\| (B) (4) - MATRIX SR 2D\| (B) (4) - MATRIX2 STANDARD 3D\| (B) (4) - MATRIX2 ULTRASOFT SR