MAUDE MDR 1018945

MDR report key: 1018945
Report number: MW5005977
Event key: 0
Event type: 3
Date of event: 2007-01-26
Date received: 2008-03-25
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 600
Health professional: 3
Initial report to FDA: 3
Event location: 0

Related Records

Product code MFX

Manufacturer Contact

Report source: P
Manufacturer link flag: N

Devices

Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	SHELHIGH, INC. PERICARDIAL PATCH	PERICARDIAL PATCH	SHELHIGH, INC.	MFX						N

Patients

Sequence	Received	Treatment	Outcome
1	2008-03-25	0	1. D

Event Narratives

D

Patient 1

PT HAD A SHELHIGH, INC., PERICARDIAL PATCH IMPLANTED IN 2007 TO AUGMENT THE RIGHT VENTRICULAR OUTFLOW TRACT. SHELHIGH'S PATCH HAD TO BE REMOVED ABOUT 6 WEEKS LATER, AND WAS REPLACED WITH ANOTHER TYPE OF GRAFT MATERIAL. PT SUBSEQUENTLY DIED 4 DAYS LATER.

Related GUDID Devices By Product Code

No records found.

Related PMN/PMA Records By Product Code

Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K061727	MFX	GORE PRECLUDE VESSEL GUARD	W. L. Gore & Associates, Inc.	2006-08-07
510(k)	K960532	MFX	PRECLUDE IMA SLEEVE	W. L. Gore & Associates, Inc.	1996-05-23