MAUDE MDR 840620
- MDR report key
- 840620
- Report number
- 2247123-2007-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-08-15
- Date received
- 2007-04-10
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact
- Address
- 650 LIBERTY AVE UNION NJ 07083 US
- Phone
- 908-908-9082
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | SHELHIGH VASCUPATCH | PERICARDIAL PATCH GRAFT | SHELHIGH | MFX | SHP-555-CRT17 | SHP-555-CRT17 | NOT AVAILABLE | | | N | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2007-04-10 | 0 | 1. R
|
Event Narratives
D
Patient 1
USER FACILITY NOTIFIED THE FDA OF THE EVENT SEVERAL MONTHS (APPROX 6 MO) AFTER THE EVENT. USER FACILITY DID NOT NOTIFY MFR. PT RECEIVED 1X7 CM SHELHIGH PERICARDIAL PATCH FOR CLOSURE OF CAROTID ARTERIOTOMY. TWO MONTHS POSTOP, PT EXPERIENCED BLEEDING PSEUDOANEURYSM. BLOOD CULTURES WERE OBTAINED AND WERE POSITIVE FOR GRAM (+) BACTERIA INDICATING METHICILLIN RESISTANT STAPH AUREUS INFECTION. INFECTION WAS SUSPECTED TO BE THE CAUSE OF EVENT. HOWEVER, UPON EXAMINING THE PT'S GRAFT, SURGEON INDICATED THAT THE PATCH APPEARED NORMAL AND THE SURROUNDING TISSUE AROUND THE ARTERY WAS CONSISTENT TO WHAT WOULD BE EXPECTED 2 MONTHS POST SURGERY. BLEEDING WAS CORRECTED BY SEALING THE ANASTOMOSIS WITH ADD'L SUTURES. PT WAS ADMINISTERED ANTIBIOTICS AND DISCHARGED. PT WAS SEEN SIX WEEKS LATER AFTER REINTERVENTION. NECK WOUND CELLULITIS HAD RESOLVED AND PT WAS ABLE TO RETURN TO WORK.
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 6 MONTHS AFTER INCIDENT). AFTER A THOROUGH REVIEW OF THE INFO SUPPLIED BY THE TREATING SURGEON, IT IS CONCLUDED THAT THE EVENT IS RELATED TO THE SURGICAL PROCEDURE AND IS NOT DEVICE RELATED. THE PATCH GRAFT APPEARED NORMAL, SURROUNDING TISSUE WAS NORMAL, AND THE POST SURGICAL SCAR TISSUE WAS CONSISTENT WITH WHAT IS NORMALLY EXPECTED 2 MONTHS POST SURGERY.
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 |