N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 6375721
- MDR report key
- 6375721
- Report number
- 1063481-2017-00010
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-07
- Date received
- 2017-03-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROCHELLE MANEY
- Address
- 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT | CRYOLIFE, INC. | OHA | SGPV00 | 142199 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-03 | 0 | 1. O |
Event Narratives#
D
Patient 1
"RAZOR THIN POSTERIOR MUSCLE CUFF THAT HAD A TEAR OR V-SHAPED DEFECT THAT EXTENDED DOWN TO WITHIN A MM OR SO OF HINGE POINT OF VALVE CUSP. WE RECONSTITUTED THE MUSCLE CUFF THERE AND IT WORKED OUT, ALTHOUGH POST-REPAIR ECHO SHOWED MILD PI. MUSCLE WAS SORT OF PALE ALSO - DIFFERENT SHADE OR COLOR THAN I'M USED TO. ANYWAY, PATIENT IS FINE, ALL IS WELL. JUST THOUGHT YOU SHOULD KNOW. HAVE A GREAT TIME AWAY." VIA DOCTOR. (B)(6). PATIENT IMPACT WAS LISTED AS PROLONGED SURGERY.
N
Patient 1
ACCORDING TO THE DOCTOR?S NOTES RECEIVED VIA EMAIL ON (B)(6) 2017: "RAZOR THIN POSTERIOR MUSCLE CUFF THAT HAD A TEAR OR V-SHAPED DEFECT THAT EXTENDED DOWN TO WITHIN AN MM OR SO OF HINGE POINT OF VALVE CUSP. WE RECONSTITUTED THE MUSCLE CUFF THERE AND IT WORKED OUT, ALTHOUGH POST-REPAIR ECHO SHOWED MILD PI. MUSCLE WAS SORT OF PALE ALSO - DIFFERENT SHADE OR COLOR THAN I'M USED TO. ANYWAY, PATIENT IS FINE, ALL IS WELL. JUST THOUGHT YOU SHOULD KNOW.?? A REVIEW OF TRAINING RECORDS INDICATES THAT THE TECHNICIAN WHO INSPECTED THIS ALLOGRAFT WAS APPROPRIATELY TRAINED FOR THE TASK SHE PERFORMED. THE INSPECTOR NOTED: ONE 6MM UNREPAIRED TEAR IN THE MUSCLE BAND 3MM FROM THE LSC (LEFT SEMILUNAR CUSP) ANNULUS. A DONOR REVIEW WAS ALSO PERFORMED. ACCORDING TO THE PROCESSING RECORDS, THIS ALLOGRAFT DID NOT CONTAIN ANY ATTRIBUTES THAT WOULD HAVE REJECTED THE ALLOGRAFT. GRAFT 10949532 WAS NOT RETURNED TO CRYOLIFE SO NO DIRECT OBSERVATIONS COULD BE MADE. PICTURES WERE PROVIDED FROM THE HOSPITAL.? IT IS POSSIBLE THAT THE TEAR COULD HAVE TORN CLOSER THAN 3MM WITH HANDLING AND PULLING OF THE MUSCLE BAND BY THE SURGEON, AS SEEN IN PICTURES PROVIDED. THE CERTIFICATE OF ASSURANCE WAS REVIEWED. ALL ATTRIBUTES IDENTIFIED? WERE DOCUMENTED APPROPRIATELY. AN ACCEPTABLE TEAR WAS NOTED IN THAT LOCATION, THAT MET SPECIFICATIONS. THE ROOT CAUSE OF THE EVENT IS UNKNOWN; HOWEVER, BASED ON THE INFORMATION AVAILABLE THE ISSUE MAY HAVE OCCURRED WHILE MANIPULATING THE TISSUE DURING THE PROCEDURE AS SHOWN IN THE PICTURES PROVIDED.
D
Patient 1
"RAZOR THIN POSTERIOR MUSCLE CUFF THAT HAD A TEAR OR V-SHAPED DEFECT THAT EXTENDED DOWN TO WITHIN A MM OR SO OF HINGE POINT OF VALVE CUSP. WE RECONSTITUTED THE MUSCLE CUFF THERE AND IT WORKED OUT, ALTHOUGH POST-REPAIR ECHO SHOWED MILD PI. MUSCLE WAS SORT OF PALE ALSO - DIFFERENT SHADE OR COLOR THAN I'M USED TO. ANYWAY, PATIENT IS FINE, ALL IS WELL. JUST THOUGHT YOU SHOULD KNOW. HAVE A GREAT TIME AWAY." VIA DOCTOR. SID IS (B)(6). PATIENT IMPACT WAS LISTED AS PROLONGED SURGERY.