FDA.report

MAUDE MDR 840597

MDR report key
840597
Report number
2247123-2007-00002
Event key
0
Event type
3
Date of event
1969-12-31
Date received
2007-04-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Related Records

Manufacturer Contact

Address
650 LIBERTY AVE UNION NJ 07083 US
Phone
908-908-9082
Report source
M
Manufacturer link flag
Y

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHELHIGH VASCUPATCHPERICARDIAL PATCH GRAFTSHELHIGHMFXSHP-555-CRT17SHP-555-CRT17NOT AVAILABLENRN

Patients

SequenceReceivedTreatmentOutcome
12007-04-1001. D

Event Narratives

D

Patient 1

MALE PT UNDERWENT LEFT CAROTID ENDARTERECTOMY PROCEDURE USING A SHELHIGH VASUPATCH FOR CLOSURE. HOSP REPORTS THAT PT DEVELOPED AN INFECTION AT GRAFT SITE. PT HAD READMISSION AND RETURNED TO OR AND DIED IN 2006. INCIDENT OCCURRED THE SAME YEAR. HOSP DID NOT PROVIDE NOTIFICATION TO SHELHIGH AT THE TIME OF INCIDENT. HOSP ONLY SUBMITTED A MEDWATCH REPORT SEVERAL MONTHS AFTER THE INCIDENT. LIMITED INFO WAS PROVIDED AT THAT TIME.

N

Patient 1

SHELHIGH (MFR OF THE VASCUPATCH) BECAME AWARE OF THIS EVENT AS A RESULT OF RECEIVING AN FDA MEDWATCH REPORT. THE USER FACILITY REPORTED THE EVENT ONLY TO FDA (APPROX 8 MONTHS AFTER INCIDENT). EXPLANTED DEVICE WAS NOT RETURNED TO SHELHIGH FOR EXAMINATION. DETAILS OF ANY PATHOLOGICAL EVAL WAS NOT PROVIDED BY HOSP. CULTURES THAT MAY HAVE BEEN CONDUCTED WERE NOT PROVIDED. THE INFO REGARDING THIS INCIDENT IS INSUFFICIENT TO CONDUCT AN INVESTIGATION.

Related GUDID Devices By Product Code

No records found.

Related PMN/PMA Records By Product Code

TypeSubmissionProduct codeDeviceApplicantDecision date
510(k)K061727MFXGORE PRECLUDE VESSEL GUARDW. L. Gore & Associates, Inc.2006-08-07
510(k)K960532MFXPRECLUDE IMA SLEEVEW. L. Gore & Associates, Inc.1996-05-23