N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
MAUDE MDR 8272100
- MDR report key
- 8272100
- Report number
- 1063481-2019-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-03
- Date received
- 2019-01-23
- Adverse event
- 3
- Product problem
- 0
- Patients in event
- 0
- Reporter occupation
- 0
- 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
- 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 | PULMONARY VALVE & CONDUIT SG | HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT | CRYOLIFE, INC. | OHA | SGPV00 | SGPV00 | 146707 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-23 | 0 | 1. D |
Event Narratives#
D
Patient 1
ACCORDING TO INITIAL REPORTS, CRYOLIFE SGPV00, SERIAL NUMBER: (B)(4) WAS IMPLANTED ON (B)(6) 2018 AS AN RV TO PA CONDUIT. THE PATIENT PASSED AWAY ON (B)(6) 2018 DUE TO CARDIAC FAILURE.
N
Patient 1
THE PROCESSING RECORDS FOR SGPV00, SERIAL NUMBER (B)(4) WERE REVIEWED AND IT WAS DETERMINED THAT ALL ATTRIBUTES IDENTIFIED WERE DOCUMENTED APPROPRIATELY AND THE ALLOGRAFT MET SPECIFICATIONS. THE PREVIOUS SANO SHUNT WAS REMOVED AND REPLACED WITH AN SGPV SANO SHUNT. THE PATIENT?S MEDICAL HISTORY CONTAINED ACUTE HEART FAILURE, AORTIC STENOSIS, CYANOSIS, DOUBLE OUTLET RIGHT VENTRICLE; TRUNCUS ARTERIOSUS TYPE 4, DYSPLASTIC AORTIC VALVE, LEFT CORONARY ARTERY STENOSIS, PATENT DUCTUS ARTERIOSUS, PULMONARY ATRESIA, AND VENTRICULAR SEPTAL DEFECT. THE USE OF VALVED HOMOGRAFTS AS RV-PA CONDUITS IN STAGE I OF THE MODIFIED NORWOOD PROCEDURE HAS BEEN DESCRIBED IN LITERATURE AND HAS INCREASED IN POPULARITY OVER THE BT SHUNT DUE TO IMPROVED OUTCOMES RELATING TO INCREASED POSTOPERATIVE HEMODYNAMIC STABILITY (REINHARTZ 2006, SHINKAWA 2015, CHRISTENSON 2010). THE PATIENT?S HISTORY OF SEVERE CONGENITAL HEART DISEASE, ABNORMAL CARDIAC ANATOMY, AND FAILED SANO SHUNT WERE LIKELY CONTRIBUTING FACTORS TO THE REPORTED CAUSE OF DEATH AS CARDIAC FAILURE. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE. THE RISK MANAGEMENT FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.
D
Patient 1
ACCORDING TO INITIAL REPORTS, CRYOLIFE SGPV00 SERIAL NUMBER: (B)(4) WAS IMPLANTED ON (B)(6) 2018 AS AN RV TO PA CONDUIT. THE PATIENT PASSED AWAY ON (B)(6) 2018 DUE TO CARDIAC FAILURE. NO ADDITIONAL INFORMATION.