CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
Report
- Report Number
- 2015691-2014-00941
- Event Type
- Injury
- Date Received
- April 24, 2014
- Date of Event
- January 25, 2013
- Report Date
- March 26, 2014
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSING ASSISTANT
Narratives
ADDITIONAL MANUFACTURER NARRATIVE: REPORT OF A TRANSCATHETER VALVE IMPLANTATION INSIDE OF A PREVIOUSLY IMPLANTED SURGICAL VALVE IN THE TRICUSPID POSITION AFTER AN IMPLANT DURATION OF APPROXIMATELY FOUR (4) YEARS DUE TO SEVERE REGURGITATION. IMPLANTATION OF A TRANSCATHETER HEART VALVE INSIDE A DEGENERATED ONE IS A LESS INVASIVE PROCEDURE TO TREAT VALVULAR DISEASE. BIOPROSTHETIC VALVE DYSFUNCTION ENCOMPASSES MULTIPLE FAILURE MODES/MECHANISMS, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF THESE FAILURES INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STATE, IMMUNE STATUS, AND OTHER CO-MORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. HOWEVER, WITHOUT RETURN OF DEVICE AND EVALUATION (REMAINS IMPLANTED), THE SPECIFIC MECHANISM LEADING TO THIS EVENT CANNOT BE IDENTIFIED OR EVALUATED. THERE HAS BEEN NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY RELATED TO THIS EVENT. EDWARDS WILL CONTINUE TO MONITOR ALL EVENTS.
EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS LEARNED THAT A PATIENT WITH AN IMPLANTED EDWARDS BIOPROSTHETIC VALVE IN THE TRICUSPID POSITION WAS DIAGNOSED WITH SEVERE TRICUSPID REGURGITATION AFTER DURATION OF FOUR (4)YEARS AND UNDERWENT AN IMPLANT OF A TRANSCATHETER VALVE INSIDE THE PREVIOUSLY IMPLANTED ONE (VALVE IN VALVE). IT WAS ALSO LEARNED THAT AFTER THE IMPLANTATION OF THE TRANSCATHETER VALVE ON THE TRICUSPID POSITION VIA A TF APPROACH, PATIENT HAD A NON-HEMORRHAGIC STROKE AND WAS TRANSFERRED TO ANOTHER HOSPITAL FOR NEUROINTERVENTION (A CEREBRAL CT SCAN WAS PERFORMED AND INTRAVENOUS HEPARIN GIVEN). PATIENT ALSO HAD AN AORTIC MECHANICAL VALVE. WARFARIN STOPPED 3 DAYS BEFORE THE PROCEDURE WITH AN NRI 1.5 AND NO LOW-MOLECULAR-WEIGHT HEPARIN WAS GIVEN. THE PATIENT RECOVERED COMPLETELY. HOWEVER, HOWEVER, 3 DAYS LATER THE PATIENT DEVELOPED HEMIPARESIS (RIGHT ARM). ONCE AGAIN, THE CT SCAN SHOWED NO ISCHEMIA OR HEMORRHAGE. AFTER INTRAVENOUS HEPARIN, THE PATIENT RECOVERED COMPLETELY. AS PER HEALTHCARE PROVIDER, THE EVENT IS RELATED TO THE ATRIAL FIBRILLATION. HOSPITAL SUMMARY STATES THAT THE THERAPIES MENTIONED GIVEN AND THAT THE PROCEDURE WAS SUCCESSFUL. TEE WAS PERFORMED AND NO THROMBUS WAS OBSERVED TO THE LEVEL OF THE AORTIC VALVE. PATIENT MEDICAL HISTORY INCLUDES: TRICUSPID INSUFFICIENCY AND REGURGITATION, MODERATE AORTIC SEVERE CALCIFIED STENOSIS, DYSPNEA, PULMONARY DISEASE COPD, PULMONARY HYPERTENSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248857 | CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | 7000TFX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| L| R |