D
Patient 1
(B)(6), CVOR COORDINATOR OF (B)(6) HOSPITAL CLAIMED THAT A PULMONARY VALVE THAT WAS IMPLANTED FRACTURED, BUT THE SURGEON REPAIRED IT.
MAUDE MDR 3910336
- MDR report key
- 3910336
- Report number
- 1063481-2014-00027
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-06-23
- Date received
- 2014-07-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- SANDRA O'REILLY
- Address
- 1655 ROBERTS BLVD., NW KENNESAW GA 30144 US
- Phone
- 770-770-7704
- 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 ALLOGRAFT | CRYOLIFE, INC. | OHA | SGPV00 | 10413223 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-07-02 | 0 | 1. O |
Event Narratives#
N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
N
Patient 1
(B)(6), CVOR COORDINATOR OF (B)(6) HOSPITAL CLAIMED THAT A PULMONARY VALVE THAT WAS IMPLANTED FRACTURED, BUT THE SURGEON REPAIRED IT. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. IT IS LIKELY THAT THE DAMAGE OCCURRED AT THE USER FACILITY; CRYOLIFE PERSONNEL ARE TRAINED TO PROPERLY HANDLE CRYOPRESERVED ALLOGRAFTS AND NO ERRORS OR DEFICIENCIES WERE FOUND IN THE PROCESSING RECORD REVIEWS. THE INSTRUCTIONS FOR USE STATES, "CRYOPRESERVED ALLOGRAFTS ARE FRAGILE AND MUST BE HANDLED WITH CARE WHILE IN THE FROZEN STATE TO AVOID CAUSING DAMAGE TO THE ALLOGRAFT" AND "CARDIAC ALLOGRAFTS ARE HUMAN BIOLOGICAL TISSUES AND, AS SUCH PRESENT CONSIDERABLE ANATOMICAL VARIATION. SPECIFIC ALLOGRAFT ATTRIBUTES (REPRESENTING NORMAL VARIATION) AND DONOR-SPECIFIC INFORMATION IS DESCRIBED IN THE ALLOGRAFT DIAGRAM AND THE CERTIFICATE OF ASSURANCE SUPPLIED WITH EACH ALLOGRAFT."
D
Patient 1
(B)(6), CVOR COORDINATOR OF (B)(6) HOSPITAL CLAIMED THAT A PULMONARY VALVE THAT WAS IMPLANTED FRACTURED, BUT THE SURGEON REPAIRED IT.