FDA Adverse Event Injury Summary report: N

MATRIX DETACHABLE COILS

MDR report key: 1654884 · Received April 9, 2010

Report

Report Number: 2939204-2010-00640
Event Type: Injury
Date Received: April 9, 2010
Date of Event: March 19, 2010
Report Date: March 26, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: HCG
PMA / PMN Number: UNKNOWN
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PMA# OR 510K# - K050700 AND K031049. CONCLUSION: OTHER FOR 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. A REVIEW OF THE LABELING FOUND THAT THE DIRECTIONS FOR USE NOTES THAT MULTIPLE PROCEDURES MAY BE REQUIRED TO OCCLUDE AN ANEURYSM. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

Description of Event or Problem · 1

APPROXIMATELY ONE YEAR AFTER THE SUCCESSFUL COIL EMBOLIZATION OF THE RIGHT INTERNAL CAROTID ARTERY ANEURYSM, THE PATIENT UNDERWENT A SECOND PROCEDURE DURING WHICH TEN ADDITIONAL COILS WERE IMPLANTED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

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	62 YR		Required Intervention	THREE (B) (4) - MATRIX2 ULTRASOFT 360 SR\| (B) (4) - MATRIX2 STANDARD 360 SR\| TWO (B) (4) - MATRIX2 SOFT 360 SR\| (B) (4) - MATRIX2 ULTRASOFT 360 SR\| THREE (B) (4) - GDC-10 ULTRASOFT\| (B) (4) - MATRIX2 ULTRASOFT 360 SR\| (B) (4) - MATRIX2 ULTRASOFT 360 SR\| (B) (4) - MATRIX2 STANDARD 360 SR\| (B) (4) - MATRIX2 ULTRASOFT 360 SR