BIOGLUE SURGICAL ADHESIVE
Report
- Report Number
- 1063481-2013-00028
- Event Type
- Injury
- Date Received
- July 18, 2013
- Report Date
- October 17, 2013
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
ACCORDING TO THE REPORT, THE SURGEON'S COLLEAGUE CLAIMED THAT BIOGLUE CANNOT BE USED TOGETHER WITH POLYPROPYLENE SUTURES BECAUSE IT EATS AWAY AT THE MATERIAL. CRYOLIFE IS NOT AWARE OF ANY MECHANISM FOR THE INTERACTION BETWEEN BIOGLUE AND POLYPROPYLENE SUTURES THAT WOULD RESULT IN DEGRADATION OR LOSS OF FUNCTIONALITY OF POLYPROPYLENE SUTURES. SAMPLES OF TISSUE WITH SUTURE WAS SENT TO CRYOLIFE FOR EVALUATION IN RELATION TO THIS CLAIM. THE CASE INVOLVED REOPERATION ON A FEMALE PATIENT WHO UNDERWENT SURGERY IN 2009 FOR THE REPAIR OF ACUTE AORTIC DISSECTION WITH ASCENDING AORTIC REPLACEMENT WITH DACRON GRAFT. THE INITIAL SURGERY INVOLVED USE OF BIOGLUE, BUT DETAILS REGARDING THE AREA(S) WHERE BIOGLUE WAS APPLIED ARE NOT AVAILABLE. UPON REOPERATION, THE SURGEON NOTED DILATATION OF THE ASCENDING AORTA AND ARCH. HE CUT THE PROSTHESIS DOWN TO THE PROXIMAL ANASTOMOSIS AND NOTED A TEAR IN THE SUTURE LINE. HE DESCRIBED A TEAR IN THE INTIMAL AORTA AND A DISRUPTION OF A PORTION OF THE PROXIMAL SUTURE LINE. HE REMOVED THE SUTURE AND PERFORMED A MORE PROXIMAL ANASTOMOSIS TO REPLACE THE TORN AREA IN THE PREVIOUS ANASTOMOSIS. HE CONFIRMED THAT NO PSEUDOANEURYSM HAD FORMED AND THAT THERE WAS NO REDISSECTION OF TISSUE AT THE PROXIMAL SIDE OF THE GRAFT. A SAMPLE OF THE EXPLANTED MATERIAL WAS RECEIVED AND GROSS AND HISTOPATHOLOGICAL EVALUATION OF THE SAMPLE WAS PERFORMED. THE EVALUATIONS INDICATED THAT THE SUTURE DID NOT APPEAR TO BE AFFECTED BY THE PRESENCE OF BIOGLUE. THE SUTURE LOOKED SMOOTH AND CONSISTENT ALONG ITS LENGTH. THERE WERE A COUPLE AREAS WHERE THE SUTURE WAS TRANSECTED BUT IT APPEARED THAT THE SUTURE WAS CUT IN THOSE AREAS. THERE IS NOTHING TO SUGGEST THAT BIOGLUE SOMEHOW DEGRADED OR ERODED THE SUTURE. DURING THE COURSE OF THE INVESTIGATION, ADDITIONAL INFORMATION WAS RECEIVED SUGGESTING THAT THE SURGEON THOUGHT BIOGLUE MAY HAVE WEAKENED THE ANASTOMOSIS VIA DEGRADATION OF THE SUTURE OR WEAKENING OF SURROUNDING TISSUE. WEAKENING OF TISSUE COULD THEN LEAD TO PSEUDOANEURYSM FORMATION. HE FURTHER ELABORATED THAT HE HAS NOTED BROKEN SUTURES UPON REOPERATION IN PATIENTS WHO HAD RECEIVED BIOLOGICAL GLUES. HE SUGGESTED THE POSSIBILITY THAT THE BROKEN SUTURES OR TISSUE TEARS MAY BE THE RESULT OF SHEAR STRESS CAUSED BY A COMPLIANCE MISMATCH BETWEEN THE TISSUE AND POLYMERIZED BIOGLUE. HOWEVER, TISSUE OR SUTURE DAMAGE DUE TO COMPLIANCE MISMATCH IS HIGHLY UNLIKELY GIVEN THE EXTENSIVE USE OF BIOGLUE SINCE LAUNCH AND LACK OF ANY REPORTS ALLEGING TISSUE DAMAGE CONSISTENT WITH COMPLIANCE MISMATCH.
ACCORDING TO THE REPORT, THE CASE INVOLVED REOPERATION ON A FEMALE PATIENT WHO UNDERWENT SURGERY IN 2009 FOR THE REPAIR OF ACUTE AORTIC DISSECTION WITH ASCENDING AORTIC REPLACEMENT WITH DACRON GRAFT. THE OPERATIVE REPORTS FROM THE INITIAL SURGERY INDICATE THAT BIOGLUE WAS USED, BUT THE REPORTS DID NOT INCLUDE ANY DETAIL REGARDING THE AREA(S) WHERE BIOGLUE WAS APPLIED. UPON REOPERATION, THE SURGEON NOTED DILATATION OF THE ASCENDING AORTA AND ARCH. HE CUT THE PROSTHESIS DOWN TO THE PROXIMAL ANASTOMOSIS AND NOTED A TEAR IN THE SUTURE LINE. HE DESCRIBED A TEAR IN THE INTIMAL AORTA AND A DISRUPTION OF A PORTION OF THE PROXIMAL SUTURE LINE. HE REMOVED THE SUTURE AND PERFORMED A MORE PROXIMAL ANASTOMOSIS TO REPLACE THE TORN AREA IN THE PREVIOUS ANASTOMOSIS. HE CONFIRMED THAT NO PSEUDOANEURYSM HAD FORMED AND THAT THERE WAS NO REDISSECTION OF TISSUE AT THE PROXIMAL SIDE OF THE GRAFT. DURING THE COURSE OF THE INVESTIGATION, ADDITIONAL INFORMATION WAS RECEIVED SUGGESTING THAT THE SURGEON THOUGHT BIOGLUE MAY HAVE WEAKENED THE ANASTOMOSIS VIA DEGRADATION OF THE SUTURE OR WEAKENING OF SURROUNDING TISSUE. WEAKENING OF TISSUE COULD THEN LEAD TO PSEUDOANEURYSM FORMATION. HE FURTHER ELABORATED THAT HE HAS NOTED BROKEN SUTURES UPON REOPERATION IN PATIENTS WHO HAD RECEIVED BIOLOGICAL GLUES. HE SUGGESTED THE POSSIBILITY THAT THE BROKEN SUTURES OR TISSUE TEARS MAY BE THE RESULT OF SHEAR STRESS CAUSED BY A COMPLIANCE MISMATCH BETWEEN THE TISSUE AND POLYMERIZED BIOGLUE.
ACCORDING TO THE REPORT, THE CASE INVOLVED REOPERATION ON A FEMALE PATIENT WHO UNDERWENT SURGERY IN 2009 FOR THE REPAIR OF ACUTE AORTIC DISSECTION WITH ASCENDING AORTIC REPLACEMENT WITH DACRON GRAFT. THE OPERATIVE REPORTS FROM THE INITIAL SURGERY INDICATE THAT BIOGLUE WAS USED, BUT THE REPORTS DID NOT INCLUDE ANY DETAIL REGARDING THE AREA(S) WHERE BIOGLUE WAS APPLIED. UPON REOPERATION, THE SURGEON NOTED DILATATION OF THE ASCENDING AORTA AND ARCH. HE CUT THE PROSTHESIS DOWN TO THE PROXIMAL ANASTOMOSIS AND NOTED A TEAR IN THE SUTURE LINE. HE DESCRIBED A TEAR IN THE INTIMAL AORTA AND A DISRUPTION OF A PORTION OF THE PROXIMAL SUTURE LINE. HE REMOVED THE SUTURE AND PERFORMED A MORE PROXIMAL ANASTOMOSIS TO REPLACE THE TORN AREA IN THE PREVIOUS ANASTOMOSIS. HE CONFIRMED THAT NO PSEUDOANEURYSM HAD FORMED AND THAT THERE WAS NO REDISSECTION OF TISSUE AT THE PROXIMAL SIDE OF THE GRAFT. DURING THE COURSE OF THE INVESTIGATION, ADDITIONAL INFORMATION WAS RECEIVED SUGGESTING THAT THE SURGEON THOUGHT BIOGLUE MAY HAVE WEAKENED THE ANASTOMOSIS VIA DEGRADATION OF THE SUTURE OR WEAKENING OF SURROUNDING TISSUE. WEAKENING OF TISSUE COULD THEN LEAD TO PSEUDOANEURYSM FORMATION. HE FURTHER ELABORATED THAT HE HAS NOTED BROKEN SUTURES UPON REOPERATION IN PATIENTS WHO HAD RECEIVED BIOLOGICAL GLUES. HE SUGGESTED THE POSSIBILITY THAT THE BROKEN SUTURES OR TISSUE TEARS MAY BE THE RESULT OF SHEAR STRESS CAUSED BY A COMPLIANCE MISMATCH BETWEEN THE TISSUE AND POLYMERIZED BIOGLUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336054 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |