BIOGLUE SYRINGE 5-PACK, 10ML, JAPAN
Report
- Report Number
- 1063481-2024-00014
- Event Type
- Injury
- Date Received
- May 23, 2024
- Date of Event
- April 10, 2024
- Report Date
- July 15, 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
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 IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
THE MANUFACTURING RECORDS FOR BG3510-5-J, LOTS BG000888, BG000948 AND BG001088 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 AMOUNT OF BIOGLUE APPLIED, THE GROSS ABNORMALITIES OF THE NATIVE TISSUE, OR IF ANY OTHER PRODUCTS WERE USED DURING THE PROCEDURE. A PATHOLOGICAL EVALUATION WAS NOT CONDUCTED. FALSE ANEURYSM (PSEUDOANEURYSM) IS LISTED IN THE IFU AS A POTENTIAL ADVERSE EVENT RELATED TO CARDIAC AND VASCULAR PROCEDURES. PER KITAMURA, ET AL. (2018), PSEUDOANEURYSM FORMATION ¿IS NOT A RARE LATE COMPLICATION AFTER REPAIR OF ACUTE AORTIC DISSECTION (MOHAMMADI S, ET AL.) THE UNDERLYING MECHANISM OF PSEUDOANEURYSM FORMATION IS CONSIDERED TO BE ASSOCIATED WITH TISSUE CUTTING DUE THE FRAGILITY OF THE DISSECTED AORTIC WALL AT THE ANASTOMOSIS AND FROM THE CHEMICAL REACTION DUE TO THE ALDEHYDE CONTAINED IN THE GLUE MATERIAL (BINGLEY JA, ET AL.).¿ PERHAPS THE NATIVE TISSUE WAS TOO DAMAGED TO BE REPAIRED AND AN AORTIC REPLACEMENT WITH A SYNTHETIC GRAFT SHOULD HAVE BEEN CONSIDERED. FURTHERMORE, WHILE SURGICAL GLUE IS HELPFUL IN SURGERY FOR ACUTE TYPE A AORTIC DISSECTION, IT MAY ALSO CAUSE LATE PSEUDOANEURYSM FORMATION OR VALVE DETERIORATION WHEN NOT USED PROPERLY (KITAMURA, ET AL.). DR. FEHRENBACHER, ET AL. PERFORMED A RETROSPECTIVE REVIEW OF 92 CONSECUTIVE PATIENTS WHO UNDERWENT COMPLEX OPERATIONS IN WHICH BIOGLUE WAS USED. POSTOPERATIVE PSEUDOANEURYSM FORMATION OCCURRED IN 3.3% OF THE PATIENTS (FEHRENBACHER 2006). WEINER, ET AL. PRESENTED AT THE 15TH WORLD CONGRESS OF HEART DISEASE IN VANCOUVER, CANADA IN JULY 2010 THEY IDENTIFIED 97 CONSECUTIVE PATIENTS IN WHOM BIOGLUE WAS USED TO REINFORCE THORACIC AORTIC SUTURE LINES. DURING FOLLOW-UP, 2 PATIENTS WERE IDENTIFIED AS HAVING A PSEUDOANEURYSM. IN THE CONTROL GROUP, WITHOUT BIOGLUE USE, SIMILAR INCIDENCES OF PSEUDOANEURYSM FORMATION WAS NOTED (WEINER 2010). MA, ET AL. REVIEWED 233 PATIENTS WITH A MEAN FOLLOW-UP TIME OF 2.4 YEARS POST-OPERATION; A PSEUDOANEURYSM WAS DETECTED IN ONLY 1 PATIENT (0.6%). THE AUTHORS CONCLUDED, ¿THE USE OF BIOGLUE IN THORACIC AORTIC SURGERY WAS NOT ASSOCIATED WITH EXCESS INCIDENCE OF ANASTOMOTIC PSEUDOANEURYSM FORMATION FOLLOWING SURGICAL REPAIR OF THORACIC AORTIC DISEASE.¿ (MA 2017). THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THERE IS AN ASSOCIATION BETWEEN THE USE OF BIOGLUE AND THE PSEUDOANEURYSM FORMED IN THE PROCEDURE. PSEUDOANEURYSM FORMATION IS A KNOWN COMPLICATION IN STANDARD SURGICAL REPAIR OF AORTIC DISSECTIONS. ADHESIONS AND ANASTOMOTIC PSEUDOANEURYSM ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EVENTS RELATED TO CARDIAC AND VASCULAR PROCEDURES. THE CONDITION OF THE NATIVE AORTIC TISSUE AT THE TIME OF INITIAL SURGERY IS UNKNOWN. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSION CAN BE MADE AT THIS TIME. THE BIOGLUE A/DFMEA WAS REVIEWED. THE REPORTED EVENTS ARE ADDRESSED IN HAZARD STEP/ITEM # A.1 22A AND A.2 2A. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE IS INSUFFICIENT INFORMATION TO DETERMINE IF THERE IS AN ASSOCIATION BETWEEN THE USE OF BIOGLUE AND THE PSEUDOANEURYSM FORMED IN THE PROCEDURE. PSEUDOANEURYSM FORMATION IS A KNOWN COMPLICATION IN STANDARD SURGICAL REPAIR OF AORTIC DISSECTIONS. ADHESIONS AND ANASTOMOTIC PSEUDOANEURYSM ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EVENTS RELATED TO CARDIAC AND VASCULAR PROCEDURES. THE CONDITION OF THE NATIVE AORTIC TISSUE AT THE TIME OF INITIAL SURGERY IS UNKNOWN. BASED ON THE LIMITED INFORMATION AVAILABLE, NO CONCLUSION CAN BE MADE AT THIS TIME. THE REPORTED EVENTS 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. THE ROOT CAUSE OF THE OBSERVED EVENT IS NOT DEFINITIVELY KNOWN. PSEUDOANEURYSM FORMATION IS A KNOWN COMPLICATION IN STANDARD SURGICAL REPAIR OF AORTIC DISSECTIONS. ADHESIONS AND ANASTOMOTIC PSEUDOANEURYSM ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EVENTS RELATED TO CARDIAC AND VASCULAR PROCEDURES. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION- FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. THIS COMPLAINT WAS REVIEWED FOR A CAPA EVALUATION AND A CAPA IS NOT WARRANTED AT THIS TIME. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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 IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 24APRIL2024 FROM H.K., CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM, THE PATIENT HAD AN AORTIC DISSECTION WHERE A YACOUB PROCEDURE (ARCH REPLACEMENT) WAS PERFOMED. THE POSTOPERATIVE ECHO SHOWED A FALSE ANEURYSM. IT WAS REPORTED THAT THERE WAS AN ENTRY AROUND BIOGLUE USED. THE SURGEON MENTIONED THAT IT WAS UNKNOWN THAT THE FALSE ANEURYSM WAS DUE TO BIOGLUE. A REOPERATION WILL BE SCHEDULED FOR 26APRIL2024. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23MAY2024 FROM H.K., CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM, THE BIOGLUE LOT NUMBER IS POSSIBLY BG000888, BG000948 OR BG001088. THE PATIENT HAS HAD NO PROBLEMS TO DATE. DURING THE SURGERY ON (B)(6) 2024 THE AREA WHERE THE BIOGLUE WAS APPLIED WAS DETACHED. A PATHOLOGICAL EXAMINATION WAS NOT CONDUCTED ON THE BIOGLUE. THE PATIENT HAS HAD NO PROBLEMS TO DATE AFTER THE SURGERY IN APRIL. THE PHYSICIAN STATED THAT THE ABNORMALITIES WERE NOT FOUND IN THE PATIENT TISSUE, BUT IT WAS UNKNOWN WHETHER THE INVISIBLE ABNORMALITIES WERE. THE APPLICATOR TIP WAS USED. THE USED AMOUNT OF THE BIOGLUE IS UNKNOWN. NO ADDITIONAL INFORMATION IS FORTHCOMING. THIS INVESTIGATION IS RELEGATED TO BG3510-5-J LOT NUMBER: BG000888, BG000948 OR BG001088 WITH ALLEGATION OF FALSE ANEURYSM AFTER USE OF BIOGLUE.
ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 24APRIL2024 FROM H.K., CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM, THE PATIENT HAD AN AORTIC DISSECTION WHERE A YACOUB PROCEDURE (ARCH REPLACEMENT) WAS PERFORMED. THE POSTOPERATIVE ECHO SHOWED A FALSE ANEURYSM. IT WAS REPORTED THAT THERE WAS AN ENTRY AROUND BIOGLUE USED. THE SURGEON MENTIONED THAT IT WAS UNKNOWN THAT THE FALSE ANEURYSM WAS DUE TO BIOGLUE. A REOPERATION WILL BE SCHEDULED FOR (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23MAY2024 FROM H.K., CENTURY MEDICAL, INC. POST MARKET VIGILANCE TEAM, THE BIOGLUE LOT NUMBER IS POSSIBLY BG000888, BG000948 OR BG001088. THE PATIENT HAS HAD NO PROBLEMS TO DATE. DURING THE SURGERY ON (B)(6) 2024 THE AREA WHERE THE BIOGLUE WAS APPLIED WAS DETACHED. A PATHOLOGICAL EXAMINATION WAS NOT CONDUCTED ON THE BIOGLUE. THE PATIENT HAS HAD NO PROBLEMS TO DATE AFTER THE SURGERY IN APRIL. THE PHYSICIAN STATED THAT THE ABNORMALITIES WERE NOT FOUND IN THE PATIENT TISSUE, BUT IT WAS UNKNOWN WHETHER THE INVISIBLE ABNORMALITIES WERE. THE APPLICATOR TIP WAS USED. THE USED AMOUNT OF THE BIOGLUE IS UNKNOWN. NO ADDITIONAL INFORMATION IS FORTHCOMING. THIS INVESTIGATION IS RELEGATED TO BG3510-5-J LOT NUMBER: BG000888, BG000948 OR BG001088 WITH ALLEGATION OF FALSE ANEURYSM AFTER USE OF BIOGLUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2970 | BIOGLUE SYRINGE 5-PACK, 10ML, JAPAN | GLUE, SURGICAL, ARTERIES | MUQ | ARTIVION, INC. | BG3510-5-J | BG000888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |