BIOGLUE
Report
- Report Number
- 1063481-2024-00019
- Event Type
- Death
- Date Received
- July 16, 2024
- Report Date
- October 16, 2024
- Manufacturer
- ARTIVION, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ACCORDING TO THE INITIAL REPORT OF A CONFERENCE PRESENTATION OF A JAPANESE PAPER, "THE PATIENT WHO UNDERWENT TOTAL ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK FOR ACUTE TYPE A AORTIC DISSECTION WAS TRANSPORTED FROM ANOTHER HOSPITAL AFTER CARDIOPULMONARY ARREST RESUSCITATION. THE PATIENT DIED OF MULTIPLE ORGAN FAILURE ON THE 20 SICK-DAY. THE DETAIL OF THE SURGERY IS AS FOLLOWS. UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST AND ANTEROGRADE SELECTIVE CEREBRAL PERFUSION, THE AORTIC STENT GRAFT (NON-ARTIVION) WAS INSERTED AND IMPLANTED FROM ZONE 2 IN ANTEROGRADE. NON-ARTIVION ENDOPROSTHESIS WAS IMPLANTED IN THE SUBCLAVIAN ARTERY BY THE B-SAFER TECHNIQUE, THE PERIPHERAL ANASTOMOSIS WAS COMPLETED BY SUTURING THE COLLAR PORTION OF THE AORTIC STENT GRAFT INSIDE AND THE FELT STRIP OUTSIDE WITH 4-0 FILAMENT THREAD WITHOUT SHAPING OF THE STUMP. AFTER RESTARTING THE BLOOD PUMPING, NON-ARTIVION SURGICAL SEALANT WAS APPLIED. AFTER ANASTOMOSING THE LEFT COMMON CAROTID PLEXUS AND THE BRACHIOCEPHALIC ARTERY, THE PROXIMAL END WAS SHAPED OF THE STUMP BY THE BIOGLUE AND THE FELT STRIP." A SAMPLE EVALUATION WAS NOT PERFORMED AS NO PRODUCT WAS RETURNED. THE MANUFACTURING RECORDS COULD NOT BE REVIEWED AS NO LOT NUMBER COULD BE IDENTIFIED. THE FOLLOWING INFORMATION WAS NOT PROVIDED AND IS UNKNOWN: THE AMOUNT OF BIOGLUE APPLIED, THE CONDITION OF THE NATIVE TISSUE, AND ANY CO-MORBIDITIES THE PATIENT MAY HAVE HAD. THERE ARE NO SURGICAL REPORTS OR MEDICAL RECORDS AVAILABLE. WE HAVE NO WAY TO EVALUATE IF BIOGLUE WAS APPLIED PER THE IFU. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE PATIENT¿S DEMISE WAS IN ANY WAY RELATED TO THE USE OF BIOGLUE. ALTHOUGH THERE IS NO EVIDENCE OF BIOGLUE INVOLVEMENT, THE INSTRUCTIONS FOR USE LIST DEATH AS AN OBSERVED UNDESIRABLE SIDE EFFECT/ADVERSE EVENT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE BIOGLUE A/DFMEA WAS REVIEWED AND THE REPORTED EVENTS ARE ADDRESSED. THE REPORTED PRODUCT WAS NOT RETURNED TO ARTIVION AND NO LOT NUMBER WAS PROVIDED FOR AN INVESTIGATION. THE REPORT ORIGINATED FROM A PUBLICATION IN 2024. THIS COMPLAINT REPORTS ADVERSE EVENTS (AE) IDENTIFIED IN LITERATURE AND DOES NOT SPECIFY POTENTIAL CAUSES OF FAILURE. DUE TO THE LIMITED INFORMATION, IT CANNOT BE DETERMINED IF THE REPORTED EVENTS ARE DIRECTLY RELATED TO BIOGLUE. AS SUCH, NO RISK OCCURRENCE ANALYSIS WAS PERFORMED IN THIS REPORT. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
ACCORDING TO THE INITIAL REPORT OF A CONFERENCE PRESENTATION OF A JAPANESE PAPER, "THE PATIENT WHO UNDERWENT TOTAL ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK FOR ACUTE TYPE A AORTIC DISSECTION WAS TRANSPORTED FROM ANOTHER HOSPITAL AFTER CARDIOPULMONARY ARREST RESUSCITATION. THE PATIENT DIED OF MULTIPLE ORGAN FAILURE ON THE 20 SICK-DAY. THE DETAIL OF THE SURGERY IS AS FOLLOWS: UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST AND ANTEROGRADE SELECTIVE CEREBRAL PERFUSION, THE AORTIC STENT GRAFT (NON-ARTIVION) WAS INSERTED AND IMPLANTED FROM ZONE 2 IN ANTEROGRADE. NON-ARTIVION ENDOPROSTHESIS WAS IMPLANTED IN THE SUBCLAVIAN ARTERY BY THE B-SAFER TECHNIQUE, THE PERIPHERAL ANASTOMOSIS WAS COMPLETED BY SUTURING THE COLLAR PORTION OF THE AORTIC STENT GRAFT INSIDE AND THE FELT STRIP OUTSIDE WITH 4-0 FILAMENT THREAD WITHOUT SHAPING OF THE STUMP. AFTER RESTARTING THE BLOOD PUMPING, NON-ARTIVION SURGICAL SEALANT WAS APPLIED. AFTER ANASTOMOSING THE LEFT COMMON CAROTID PLEXUS AND THE BRACHIOCEPHALIC ARTERY, THE PROXIMAL END WAS SHAPED OF THE STUMP BY THE BIOGLUE AND THE FELT STRIP." ADDITIONAL INFORMATION WAS RECEIVED: "1. WHAT LOT OF BIOGLUE WAS USED? - BG000858 2. HOW MUCH BIOGLUE WAS APPLIED? ¿ APPROXIMATELY 2 BIOGLUES 3. MAY WE HAVE A COPY OF THE PATIENT¿S MEDICAL RECORDS AND OPERATIVE NOTES? ¿ REQUESTED, BUT THE INFORMATION COULD NOT BE OBTAINED 4. DATE OF SURGERY: (B)(6) 2023 5. PHYSICIAN¿S COMMENT: BIOGLUE IS NOT RELATED TO THE DEATH." A SAMPLE EVALUATION WAS NOT PERFORMED AS NO PRODUCT WAS RETURNED. THE MANUFACTURING RECORDS FOR BG3510-5-J, LOT BG000858 WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND TO BE RELATED TO THE COMPLAINT. THE FOLLOWING INFORMATION WAS NOT PROVIDED AND IS UNKNOWN: THE CONDITION OF THE NATIVE TISSUE, AND ANY CO-MORBIDITIES THE PATIENT MAY HAVE HAD. THERE ARE NO SURGICAL REPORTS OR MEDICAL RECORDS AVAILABLE. WE HAVE NO WAY TO EVALUATE IF BIOGLUE WAS APPLIED PER THE IFU. THE PHYSICIAN INDICATED THAT THE PATIENT¿S DEATH WAS NOT RELATED TO BIOGLUE. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THE PATIENT¿S DEMISE WAS IN ANY WAY RELATED TO THE USE OF BIOGLUE. ALTHOUGH THERE IS NO EVIDENCE OF BIOGLUE INVOLVEMENT, AND THE PHYSICIAN INDICATED THAT BIOGLUE WAS NOT RELATED TO THE PATIENT¿S DEATH, THE INSTRUCTIONS FOR USE LIST DEATH AS AN OBSERVED UNDESIRABLE SIDE EFFECT/ADVERSE EVENT. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE BIOGLUE A/DFMEA WAS REVIEWED AND THE REPORTED EVENTS ARE ADDRESSED. THE REPORTED PRODUCT WAS NOT RETURNED TO ARTIVION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED. NO ISSUES WERE FOUND RELATED TO THE REPORTED LOT#. THE REPORT ORIGINATED FROM A PUBLICATION IN 2024. THIS COMPLAINT REPORTS ADVERSE EVENTS (AE) IDENTIFIED IN LITERATURE AND DOES NOT SPECIFY POTENTIAL CAUSES OF FAILURE. DUE TO THE LIMITED INFORMATION AND UNKNOWN TIME TO EVENTS, IT CANNOT BE DETERMINED IF THE REPORTED EVENTS ARE DIRECTLY RELATED TO BIOGLUE. AS SUCH, NO RISK OCCURRENCE ANALYSIS WAS PERFORMED IN THIS REPORT. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
ACCORDING TO THE INITIAL REPORT OF A CONFERENCE PRESENTATION OF A JAPANESE PAPER, "THE PATIENT WHO UNDERWENT TOTAL ARCH REPLACEMENT AND FROZEN ELEPHANT TRUNK FOR ACUTE TYPE A AORTIC DISSECTION WAS TRANSPORTED FROM ANOTHER HOSPITAL AFTER CARDIOPULMONARY ARREST RESUSCITATION. THE PATIENT DIED OF MULTIPLE ORGAN FAILURE ON THE 20 SICK-DAY. THE DETAIL OF THE SURGERY IS AS FOLLOWS. UNDER DEEP HYPOTHERMIC CIRCULATORY ARREST AND ANTEROGRADE SELECTIVE CEREBRAL PERFUSION, THE AORTIC STENT GRAFT (NON-ARTIVION) WAS INSERTED AND IMPLANTED FROM ZONE 2 IN ANTEROGRADE. NON-ARTIVION ENDOPROSTHESIS WAS IMPLANTED IN THE SUBCLAVIAN ARTERY BY THE B-SAFER TECHNIQUE, THE PERIPHERAL ANASTOMOSIS WAS COMPLETED BY SUTURING THE COLLAR PORTION OF THE AORTIC STENT GRAFT INSIDE AND THE FELT STRIP OUTSIDE WITH 4-0 FILAMENT THREAD WITHOUT SHAPING OF THE STUMP. AFTER RESTARTING THE BLOOD PUMPING, NON-ARTIVION SURGICAL SEALANT WAS APPLIED. AFTER ANASTOMOSING THE LEFT COMMON CAROTID PLEXUS AND THE BRACHIOCEPHALIC ARTERY, THE PROXIMAL END WAS SHAPED OF THE STUMP BY THE BIOGLUE AND THE FELT STRIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694328 | BIOGLUE | GLUE, SURGICAL, ARTERIES | MUQ | ARTIVION, INC. | BG3510-5-J | BG000858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death |