BIOGLUE SURGICAL ADHESIVE
Report
- Report Number
- 1063481-2013-00018
- Event Type
- Injury
- Date Received
- June 5, 2013
- Date of Event
- May 22, 2013
- Report Date
- May 31, 2013
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
ACCORDING TO THE REPORT, BIOGLUE (BG3510-5-J, EXACT LOT UNKNOWN) WAS USED IN A HEMIARCH AORTA REPLACEMENT SURGERY FOR ACUTE AORTIC DISSECTION ON (B)(6) 2013. BIOGLUE WAS APPLIED TO THE PROXIMAL FALSE LUMEN. HOWEVER, SINCE THE BIOGLUE DID NOT ADHERE TO THE TISSUE, THE SINUS OF VALSALVA RUPTURED. THEREFORE, AN EMERGENCY OPERATION WAS PERFORMED ON (B)(6) 2013, AND THE PATIENT WAS HOSPITALIZED IN AN INTENSIVE-CARE UNIT AT THE TIME OF THE REPORT. THE AMOUNT OF THE APPLIED BIOGLUE WAS A "PROPER QUANTITY" (TWO SYRINGES). BIOGLUE WAS USED WITH GREAT CAUTION SUCH AS PRIMING. THE SURGEON SAID THAT THIS DISSECTION WAS DISSECTION OF ADVENTITIA AND ASSUMED THE SINUS OF VALSALVA WAS RUPTURED BECAUSE THE ADVENTITIA WAS VERY THIN. ADDITIONAL INFORMATION WAS OBTAINED THROUGH A FACE-TO-FACE MEETING WITH JAPANESE SURGEONS DURING THE 2014 (B)(6) ON 04/28/2014. DR. (B)(6) MENTIONED THAT HIS FRIEND AND COLLEAGUE, DR. (B)(6), HAD AN EXPERIENCE RELATING TO BIOGLUE COMING OUT OF THE FALSE LUMEN AT THE LEVEL OF THE STUMP. DR. (B)(6) NOW USES FIBRIN SEALANT FOR OBLITERATING THE FALSE LUMEN OF THE ROOT. CENTURY MEDICAL, INC. (CMI) IS THE MANUFACTURER OF RECORD FOR BIOGLUE IN JAPAN. ALL COMPLAINT INFORMATION IS COLLECTED THROUGH CMI AND THEY ARE THE INTERMEDIARY FOR OBTAINING INFORMATION. THE ADDITIONAL INFORMATION WAS PROVIDED TO CMI TO EVALUATE IF THE EVENT WAS PREVIOUSLY REPORTED TO CRYOLIFE, AND CMI VERIFIED IT WAS PREVIOUSLY INVESTIGATED UNDER (B)(4). FURTHER VERIFICATION WAS REQUESTED FROM CMI AS THERE ARE DISCREPANCIES BETWEEN THE TWO COMPLAINT DESCRIPTIONS. THE ADDITIONAL INFORMATION RECEIVED DURING THE (B)(6) MEETING DOES NOT MENTION RUPTURING OF THE VALSALVA AS STATED IN THE INITIAL INFORMATION FOR (B)(4). CMI VERIFIED THAT DR. (B)(6) CONDUCTED THE PROCEDURE ALONG WITH DR. (B)(6) FOR THE CASE REPORTED IN (B)(4). CMI ALSO EXPLAINED THAT AT THE (B)(6) MEETING, DR. (B)(6) STATED THAT HE HAD AN EXPERIENCE WHERE BIOGLUE WAS APPLIED ONLY 2CM DEEP AND THAT HAD CAUSED THE REPORTED EVENT. CMI THEN REALIZED THAT DR. (B)(6) WAS REFERRING TO THE CASE REPORTED IN (B)(4). THEREFORE, (B)(4) WAS RE-OPENED FOR EVALUATION OF THIS ADDITIONAL INFORMATION. MANUFACTURING RECORDS FOR THE POSSIBLE LOT NUMBERS WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. A REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, A CAUSE OF THE OBSERVED COMPLICATIONS CANNOT DEFINITIVELY BE DETERMINED. HOWEVER, IT IS FEASIBLE THAT THE FALSE LUMEN WAS NOT COMPLETELY CLEANED OF ANY THROMBUS AND/OR DEBRIS WHICH WOULD PREVENT BIOGLUE FROM ADHERING PROPERLY TO THIS TISSUE. THE COMMENT FROM DR. (B)(6) INDICATING THAT DR. (B)(6), WHO CONDUCTED THE PROCEDURE THAT IS THE SUBJECT OF THIS COMPLAINT ALONG WITH DR. (B)(6), EXPERIENCED BIOGLUE "COMING OUT OF THE FALSE LUMEN," FURTHER SUPPORTS THIS. ADDITIONALLY, THE SURGEON INDICATED THAT THE TISSUE WAS VERY THIN WHICH LIKELY CONTRIBUTED TO THE RUPTURE OF THE VALSALVA. IF THE DISSECTION EXTENDED TO THE OUTER LAYERS OF THE MEDIA OR ADVENTITIA, THIS WOULD CREATE A WEAKENED AREA THAT COULD POTENTIALLY RUPTURE. ALTHOUGH A DEFINITIVE CONCLUSION COULD NOT BE MADE, APPLICATION OF BIOGLUE TO AN INAPPROPRIATELY PREPARED FIELD COULD RESULT IN POOR ADHERENCE. INCOMPLETE OBLITERATION OF THE FALSE LUMEN COULD LEAD TO EXTENSION OF THE DISSECTION AND POSSIBLE RUPTURE. THE BIOGLUE INSTRUCTIONS FOR USE (IFU) INCLUDES ADEQUATE GUIDANCE AND INSTRUCTION IN PROPERLY PREPARING THE BIOGLUE APPLICATION SITE.
ACCORDING TO THE REPORT, BIOGLUE (BG3510-5-J, LOT UNKNOWN) WAS USED IN HEMIARCH AORTA REPLACEMENT SURGERY FOR ACUTE AORTIC DISSECTION IN (B)(6) 2013. AND IT WAS APPLIED TO PROXIMAL FALSE LUMEN. HOWEVER SINCE THE BIOGLUE DID NOT ADHERE TO THE TISSUE, THE SINUS OF VALSALVA WAS RUPTURED. THEREFORE, THE EMERGENCY OPERATION WAS PERFORMED IN (B)(6) 2013, AND THE PATIENT IS HOSPITALIZING IN AN INTENSIVE-CARE UNIT AT THE MOMENT. AMOUNT OF THE APPLIED BIOGLUE WAS PROPER QUANTITY (TWO SYRINGES). BIOGLUE WAS USED WITH GREAT CAUTION SUCH AS PRIMING. THE SURGEON SAID THAT THIS DISSECTION WAS DISSECTION OF ADVENTITIA AND ASSUMED THE SINUS OF VALSALVA WAS RUPTURED BECAUSE THE ADVENTITIA WAS VERY THIN. THE LOT NUMBER OF BIOGLUE USED IN THE CASE ASSOCIATED WITH COMPLAINT (B)(4) IS NOT KNOWN. THE DISTRIBUTOR PROVIDED THE LOT NUMBERS (12MJX002, 12MJX003, 12MJX004, 12MJX005, 12MJX006, 12MJX007, 12MJX008, 12MJX009, 12MJX010) PROVIDED TO THE HOSPITAL IN THE THREE MONTH PERIOD PRIOR TO THE SURGERY IN WHICH BIOGLUE WAS USED. DUE TO THE NUMBER OF LOTS PROVIDED, A REVIEW OF THE ASSOCIATED DHRS IS NOT FEASIBLE OR WARRANTED. HOWEVER, A REVIEW OF PREVIOUS COMPLAINTS FOR THESE LOTS WAS PERFORMED AND FIVE COMPLAINTS (COMPLAINTS (B)(4)) WERE IDENTIFIED. OF THESE COMPLAINTS, THE LOT NUMBER WAS ONLY DEFINITIVELY KNOWN IN COMPLAINT (B)(4) (12MJX008). A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED FOR POSSIBLE LOT NUMBER 12MJX008 DURING THE INVESTIGATION OF COMPLAINT (B)(4) AND NO ISSUES WERE REPORTED DURING MANUFACTURING, THE RECORDS WERE COMPLETE, ACCURATE, AND FULLY APPROVED, AND THAT COMPLAINT IS NOT RELATED TO THE EVENT FOR (B)(4). A CLINICAL AND MEDICAL REVIEW WAS PERFORMED AND BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT A DEFINITIVE CONCLUSION CANNOT BE DRAWN REGARDING THE CAUSE OF THE COMPLICATION OBSERVED IN THIS PATIENT. THE DESCRIPTION OF THE EVENT IS NOT ENTIRELY CLEAR AND IT IS ASSUMED THAT THE DISSECTION EXTENDED INTO A SINUS OF VALSALVA. IF THE DISSECTION EXTENDED TO THE OUTER LAYERS OF THE MEDIA OR ADVENTITIA, THIS WOULD CREATE A WEAKENED AREA THAT COULD POTENTIALLY RUPTURE. IT IS FEASIBLE TO SPECULATE THAT THE FALSE LUMEN WAS NOT COMPLETELY CLEANED OF ANY THROMBUS AND/OR DEBRIS WHICH WOULD PREVENT BIOGLUE FROM ADHERING PROPERLY TO THE TISSUE. ADDITIONALLY, THE SURGEON INDICATED THAT THE TISSUE WAS VERY THIN WHICH LIKELY CONTRIBUTED TO THE RUPTURE OF THE SINUS OF VALSALVA. TO FURTHER DETERMINE A ROOT CAUSE, TISSUES FOR PATHOLOGICAL EVALUATION WOULD BE REQUIRED. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTION IS WARRANTED; HOWEVER, ADDITIONAL ACTION IS NOT WARRANTED AT THIS TIME. 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.
ADDITIONAL INFORMATION WAS RECEIVED ABOUT THIS EVENT DURING A FACE-TO-FACE MEETING WITH (B)(6) SURGEONS DURING THE 2014(B)(6) ANNUAL MEETING. IT WAS CONFIRMED THAT THE COMMENTS ARE THE SAME AS THE REPORTED EVENT FOR THIS ADVERSE EVENT. DR. (B)(6) ALSO CONDUCTED THE PROCEDURE ALONG WITH DR. (B)(6). THE SURGEON MENTIONED THAT HIS FRIEND AND COLLEAGUE, DR. (B)(6), ALSO HAD SIMILAR EXPERIENCE AS RELATED TO BIOGLUE COMING OUT OF THE FALSE LUMEN AT THE LEVEL OF THE STUMP. DR. (B)(6) NOW USES FIBRIN SEALANT FOR OBLITERATING THE FALSE LUMEN OF THE ROOT. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
ACCORDING TO THE REPORT, BIOGLUE WAS USED IN HEMIARCH AORTA REPLACEMENT SURGERY FOR ACUTE AORTIC DISSECTION ON (B)(6) 2012. BIOGLUE WAS APPLIED TO THE FALSE LUMEN. A RUPTURE SUBSEQUENTLY OCCURRED IN A SINUS AND WAS REPORTEDLY RELATED TO THE FAILURE OF BIOGLUE TO ADHERE TO THE TISSUE. THE PATIENT UNDERWENT EMERGENCY SURGERY ON (B)(6) 2013 AND IS CURRENTLY IN INTENSIVE CARE AT THE HOSPITAL. THE SURGEON ALSO INDICATED THAT THE TISSUE ADVENTITIA WAS VERY THIN AND ATTRIBUTED THE RUPTURE TO THE THIN ADVENTITIA. THEREFORE, IT IS NOT CLEAR IF THE SURGEON IS ATTRIBUTING THIS FAILURE TO BIOGLUE OR THE THIN ADVENTITIA.
ACCORDING TO THE REPORT, BIOGLUE WAS USED IN HEMIARCH AORTA REPLACEMENT SURGERY FOR ACUTE AORTIC DISSECTION ON (B)(6) 2012. BIOGLUE WAS APPLIED TO THE FALSE LUMEN. A RUPTURE SUBSEQUENTLY OCCURED IN A SINUS AND WAS REPORTEDLY RELATED TO THE FAILURE OF BIOGLUE TO ADHERE TO THE TISSUE. THE PATIENT UNDERWENT EMERGENCY SURGERY ON (B)(6) 2013 AND IS CURRENTLY IN INTENSIVE CARE AT THE HOSPITAL. THE SURGEON ALSO INDICATED THAT THE TISSUE ADVENTITIA WAS VERY THIN AND ATTRIBUTED THE RUPTURE TO THE THIN ADVENTITIA. THEREFORE, IT IS NOT CLEAR IF THE SURGEON IS ATTRIBUTING THIS FAILURE TO BIOGLUE OR THE THIN ADVENTITIA.
ACCORDING TO THE REPORT, BIOGLUE WAS USED IN HEMIARCH AORTA REPLACEMENT SURGERY FOR ACUTE AORTIC DISSECTION ON (B)(6) 2012. BIOGLUE WAS APPLIED TO THE FALSE LUMEN. A RUPTURE SUBSEQUENTLY OCCURED IN A SINUS AND WAS REPORTEDLY RELATED TO THE FAILURE OF BIOGLUE TO ADHERE TO THE TISSUE. THE PATIENT UNDERWENT EMERGENCY SURGERY ON (B)(6) 2013 AND IS CURRENTLY IN INTENSIVE CARE AT THE HOSPITAL. THE SURGEON ALSO INDICATED THAT THE TISSUE ADVENTITIA WAS VERY THIN AND ATTRIBUTED THE RUPTURE TO THE THIN ADVENTITIA. THEREFORE, IT IS NOT CLEAR IF THE SURGEON IS ATTRIBUTING THIS FAILURE TO BIOGLUE OR THE THIN ADVENTITIA.
ACCORDING TO THE REPORT, BIOGLUE WAS USED IN HEMIARCH AORTA REPLACEMENT SURGERY FOR ACUTE AORTIC DISSECTION ON (B)(6) 2012. BIOGLUE WAS APPLIED TO THE FALSE LUMEN. A RUPTURE SUBSEQUENTLY OCCURED IN A SINUS AND WAS REPORTEDLY RELATED TO THE FAILURE OF BIOGLUE TO ADHERE TO THE TISSUE. THE PATIENT UNDERWENT EMERGENCY SURGERY ON (B)(6) 2013 AND IS CURRENTLY IN INTENSIVE CARE AT THE HOSPITAL. THE SURGEON ALSO INDICATED THAT THE TISSUE ADVENTITIA WAS VERY THIN AND ATTRIBUTED THE RUPTURE TO THE THIN ADVENTITIA. THEREFORE, IT IS NOT CLEAR IF THE SURGEON IS ATTRIBUTING THIS FAILURE TO BIOGLUE OR THE THIN ADVENTITIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249298 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE, INC. | BG3510-5-J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R |