D
Patient 1
ACCORDING TO THE REPORT, A PATIENT HAD TRANSYMYOCARDIAL REVASCULARIZAITON (TMR), AORTIC VALVE REPLACEMENT (AVR), AND CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2015 AND EXPERIENCED VENTRICULAR ARRYTHMIA ON (B)(6) 2015.
MAUDE MDR 4782966
- MDR report key
- 4782966
- Report number
- 1063481-2015-00067
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-03-18
- Date received
- 2015-05-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- 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 | SOLOGRIP III HANDPIECE | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE | CRYOLIFE, INC. | MNO | HP-SG3 | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-05-19 | 0 | 1. L |
Event Narratives#
N
Patient 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
N
Patient 1
ACCORDING TO THE CASE REPORT FORMS (CRFS) AND REPORT, THE PATIENT HAD TRANSYMYOCARDIAL REVASCULARIZAITON (TMR), AORTIC VALVE REPLACEMENT (AVR), AND CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2015 AND EXPERIENCED VENTRICULAR ARRYTHMIA ON (B)(6) 2015. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2015 FROM THE CLINICAL SITE INDICATED THAT THE INTERVENTION PERFORMED IN RESPONSE TO THE ARRTHYMIA WAS IMPLANTATION OF A PACER. ADDITIONAL INFORMATION FROM THE REPRESENTATIVE ON 05/27/2015 INDICATED THAT THE VALVE REPLACEMENT PERFORMED DID NOT UTILIZE A CRYOVALVE. ADDITIONALLY, THE HOSPITAL HAS NOT BEEN KEEPING TRACK OF HANDPIECE LOT NUMBERS USED. THE REPRESENTATIVE HAS REQUESTED THAT THEY DO SO FOR FUTURE PROCEDURES. SHIPPING RECORDS INDICATED THE FOLLOWING POSSIBLE SOLOGRIP III HANDPIECE LOT NUMBERS WERE SENT TO THE HOSPITAL IN THE SIX MONTHS PRIOR TO THE PROCEDURE ((B)(6) 2014 - (B)(6) 2015): TA-04041, TA-04043, TA-04045, TA-04049, AND TA-04053.THE MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED FOR POSSIBLE LOT NUMBERS TA-04041, TA-04043, TA-04045, TA-04049, AND TA-04053. A MANUFACTURER'S REPORT WAS NOT REQUESTED FROM PARKER HANNIFIN AS ALL DOCUMENTATION WAS AVAILABLE IN HOUSE. NO SAMPLE WAS RECEIVED FROM THE CUSTOMER FOR EXAMINATION. NON-CONFORMANCE REPORTS (NCRS), REWORKS, AND WAIVERS INCLUDED IN THE INCOMING INSPECTION BATCH RECORD WERE REVIEWED AND DETERMINED TO BE UNRELATED TO THE REPORTED EVENT. ALL APPROVED UNITS UNDERWENT FINAL TESTING AND INSPECTION AND RECEIVED PASSING RESULTS. THROUGH REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS, NO ROOT CAUSE OF THE REPORTED EVENT COULD BE DETERMINED. ACCORDING TO ALL DOCUMENTATION THE APPROVED HANDPIECES AND THEIR SUBASSEMBLIES WERE CONSTRUCTED FROM APPROVED COMPONENTS AND PASSED ALL FINAL TESTING. INFORMATION FROM THE CRFS INDICATE THE (B)(6) YEAR OLD MALE PATIENT UNDERWENT TMR AS AN ADJUNCT TO CABG AND AORTIC VALVE REPLACEMENT WHILE ON CARDIOPULMONARY BYPASS. THE PATIENT HAD DIABETES, A FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERCHOLESTEROLEMIA, PRIOR CABG AND PERCUTANEOUS CORONARY INTERVENTION (PCI) AND A HISTORY OF SMOKING. THE PRE-OPERATIVE EJECTION FRACTION WAS 60%. A TOTAL OF 14 TMR CHANNELS WERE PLACED WHILE THE PATIENT WAS HEPARINIZED. THE CABG PROCEDURE TOOK PLACE BEFORE TMR, IN WHICH ONE GRAFT WAS PLACED TO THE PATENT DUCTUS ARTERIOSUS (PDA). TWO DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED VENTRICULAR ARRHYTHMIA. THE PATIENT WAS DISCHARGED 9 DAYS AFTER THE TMR PROCEDURE AND 41 DAYS AFTER SURGERY, THE PATIENT DID NOT HAVE ANGINA. THE INCIDENCE OF VENTRICULAR ARRHYTHMIAS HAS BEEN REPORTED AS AN EARLY COMPLICATION DURING THE RECOVERY PERIOD FOLLOWING CABG ALONE, TMR ALONE, AND TMR+CABG IN THE LITERATURE. A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL (RCT) BY ALLEN ET AL. (1999), FOUND A 12% INCIDENCE OF VENTRICULAR FIBRILLATION IN PATIENTS UNDERGOING SOLE THERAPY TMR WITH THE HOLMIUM:YAG LASER. SIMILAR RATES WERE REPORTED IN A PROSPECTIVE MULTI-CENTER TRIAL BY FRAZIER ET AL. (1999), USING A C02 LASER FOR SOLE THERAPY TMR, WITH VENTRICULAR TACHYCARDIA OR VENTRICULAR FIBRILLATION OCCURRING IN 8% OF PATIENTS. THE INCIDENCE OF VENTRICULAR ARRHYTHMIAS FOLLOWING TMR+CABG HAS ALSO BEEN REPORTED IN A MULTI-CENTER, PROSPECTIVE, RCT BY ALLEN ET AL. (2000). THIS TRIAL REPORTED THE INCIDENCE OF VENTRICULAR FIBRILLATION IN 132 TMR+ CABG PATIENTS AT 4% WAS NOT DIFFERENT THAN 131 PATIENTS WHO UNDERWENT CABG ALONE AT 2% (P=0.7). VENTRICULAR ARRTHYMIA HAS BEEN A REPORTED ADVERSE EVENT AFTER CABG PROCEDURES WITH OR WITHOUT ADJUNCTIVE TMR. THIS IS NOT AN UNEXPECTED EVENT EARLY AFTER CARDIAC PROCEDURES.VENTRICULAR ARRYTHMIA IS A COMMON DYSRHYTHMIA SEEN IN PATIENTS WITH OTHER CARDIOVASCULAR DISEASES SUCH AS HYPERCHOLESTEROLEMIA AND CORONARY ARTERY DISEASE, WHICH WERE NOTED IN THIS PATIENT'S MEDICAL HISTORY. ADDITIONALLY, THE PATIENT HAD A HISTORY OF DIABETES AND SMOKING WITH PRIOR CABG AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURES. FURTHERMORE, TRANSIENT DYSRHYTHMIAS ARE KNOWN TO OCCUR FOLLOWING CABG AND CONCOMITANT TMR PROCEDURES. ALSO, AORTIC VALVE REPLACEMENT SURGERY CAN POTENTIALLY INJURE THE AV NODE PREDISPOSING THE PATIENT TO VENTRICULAR ARRYTHMIAS. ADEQUATE PRECAUTIONS AND WARNINGS ARE PRESENT IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU).
D
Patient 1
ACCORDING TO THE REPORT, A PATIENT HAD TRANSYMYOCARDIAL REVASCULARIZATION (TMR), AORTIC VALVE REPLACEMENT (AVR), AND CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2015 AND EXPERIENCED VENTRICULAR ARRYTHMIA ON (B)(6) 2015.