BIOGLUE SURGICAL ADHESIVE
Report
- Report Number
- 1063481-2014-00021
- Event Type
- Injury
- Date Received
- May 28, 2014
- Report Date
- April 28, 2014
- 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.
THE SURGEON STATED THAT WHEN HE SUTURED THROUGH BIOGLUE, THE POLYMERIZED BIOGLUE CAME OUT OF THE TOP PART OF THE STUMP AND WAS NOT ADHERED, AND IN SOME CASES HE ENDED UP WITH A LUMP WHERE BIOGLUE WAS APPLIED, WHICH PROTRUDED INTO THE TRUE LUMEN AND DID NOT CONFORM WELL TO THE ROOT. THE SURGEON'S TECHNIQUE INCLUDES APPLYING BIOGLUE INTO THE FALSE LUMEN, ALLOWING TO POLYMERIZE, AND THEN CUTTING THE VESSEL, WHICH IS WHEN HE ENCOUNTERS THE HARDNESS OF THE BIOGLUE. POSSIBLE LOT NUMBERS WERE DETERMINED THROUGH SHIPPING RECORDS 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 THE REPORT, A CAUSE OF THE EVENTS OBSERVED BY THE SURGEON COULD NOT BE DEFINITIVELY DETERMINED. HOWEVER, BASED ON THE BONDING STRENGTH AND MODE OF ACTION OF BIOGLUE, A PLAUSIBLE EXPLANATION IS FAILURE TO FULLY CLEAR THE FALSE LUMEN OF ANY BLOOD, THROMBUS, AND/OR DEBRIS WHICH WOULD INTERFERE WITH ADHERENCE OF BIOGLUE TO THE TISSUE. IF BIOGLUE IS NOT FULLY ADHERED TO THE TISSUE, IT IS POSSIBLE FOR IT TO MIGRATE OUT OF THE FALSE LUMEN DURING SUTURING AS OBSERVED BY THE SURGEON. THE SURGEON'S SECOND OBSERVATION THAT IN SOME CASES HE ENDED UP WITH A LUMP WHERE BIOGLUE WAS APPLIED, WHICH PROTRUDED INTO THE TRUE LUMEN AND DID NOT CONFORM WELL TO THE ROOT IS LIKELY DUE TO OVERFILLING THE FALSE LUMEN WITH BIOGLUE AND NOT MAINTAINING THE ANATOMICAL SHAPE OF THE AORTA DURING BIOGLUE APPLICATION WHICH CAN BE ACCOMPLISHED BY INSERTING GAUZE OR A BALLOON CATHETER INTO THE TRUE LUMEN. THE SURGEON'S COMMENT THAT HE ENCOUNTERS THE HARDNESS OF BIOGLUE WHEN HE CUTS THE VESSEL AFTER BIOGLUE HAS BEEN DELIVERED INTO THE FALSE LUMEN LIKELY RESULTS FROM APPLICATION OF TOO MUCH BIOGLUE INTO THE FALSE LUMEN. IT APPEARS THAT BIOGLUE IS BEING APPLIED IN TOO THICK OF A LAYER AND NOT COMPLETELY FILLING THE PROXIMAL FALSE LUMEN IN THE AORTIC ROOT. THE JAPANESE INSTRUCTIONS FOR USE (IFU) INSTRUCTS SURGEONS TO APPLY BIOGLUE INTO THE FALSE LUMEN AT A DEPTH OF 2CM AND A THICKNESS OF 2MM. IT ALSO ADVISES THAT APPLYING BIOGLUE BEYOND THE RECOMMENDED THICKNESS WILL RESULT IN REDUCED FLEXIBILITY. A POSSIBLE ROOT CAUSE FOR THE REPORTED EVENT IS USER ERROR. IT IS LIKELY THAT IMPROPER PREPARATION OF THE TARGET FIELD AND IMPROPER APPLICATION TECHNIQUE (OVER FILLING AND NOT MAINTAINING THE ANATOMICAL SHAPE OF THE AORTA) ARE THE ROOT CAUSES OF THE OBSERVED COMPLICATIONS. A SECOND POSSIBLE ROOT CAUSE IS INADEQUATE SURGEON TRAINING.
THE SURGEON STATED THAT WHEN HE SUTURED THROUGH BIOGLUE, THE POLYMERIZED BIOGLUE CAME OUT OF THE TOP PART OF THE STUMP AND WAS NOT ADHERED, AND IN SOME CASES HE ENDED UP WITH A LUMP WHERE BIOGLUE WAS APPLIED, WHICH PROTRUDED INTO THE TRUE LUMEN AND DID NOT CONFORM WELL TO THE ROOT.
THE SURGEON STATED THAT WHEN HE SUTURED THROUGH BIOGLUE, THE POLYMERIZED BIOGLUE CAME OUT OF THE TOP PART OF THE STUMP AND WAS NOT ADHERED, AND IN SOME CASES HE ENDED UP WITH A LUMP WHERE BIOGLUE WAS APPLIED, WHICH PROTRUDED INTO THE TRUE LUMEN AND DID NOT CONFORM WELL TO THE ROOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313488 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE, INC. | BG3510-5-J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |