BIOGLUE SURGICAL ADHESIVE
Report
- Report Number
- 1063481-2014-00019
- Event Type
- Injury
- Date Received
- April 25, 2014
- Report Date
- April 16, 2014
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MUQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.
ACCORDING TO THE REPORT, BIOGLUE APPLIED TO ANASTOMOSIS FASCIA PATCH USED TO SEAL DURA FOLLOWING POSTERIOR FOSSA PROCEDURE. INFECTION OCCURRED IN SURGICAL AREA. PATIENT REQUIRED REOPERATION WITH BIOGLUE DETECTED IN BORE HOLES. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED "PATIENT RE-OPERATION 5 TIMES DURING AUTUMN 2013 DUE WOUND INFECTION, FINALLY HEALED AFTER ALL BIOGLUE REMOVED FROM WOUND ALSO FROM SMALL BONE DRILL HOLES FOR DURAFASCIA SUTURES." FURTHER ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR AND SURGEON INDICATED THE FOLLOWING: "A MENINGEOMA [MENINGIOMA] WAS OPERATED ON FROM THE POSTERIOR CRANIAL FOSSA ON (B)(6) 2013; THE DURA WAS REPLACED WITH THE PATIENT'S OWN MUSCULAR FASCIA; SUTURES WERE MADE FROM THE UPPER PART OF THE CRANIAL OPENING TO THE CRANIAL BONE, BY MEANS OF THE STRING BORE HOLES (THERE ARE DURAL VENOUS SINUSES IN THE AREA THAT DO NOT ALLOW SUTURING); AND THE FASCIA WAS CLOSED WITH BIOGLUE. THE BORE HOLES TOO WERE CLOSED WITH BIOGLUE, TO PREVENT LEAKING OF CEREBROSPINAL FLUID. THE WOUND HAD TURNED NECROTIC, AND PUS WAS OBSERVED IN THE AREA FROM THE SUBCUTANEOUS TISSUE UP TO THE CRANIAL-BONE OPENING DURING A DEBRIDEMENT SURGERY ON (B)(6) 2013; THE BONE FRAGMENT AND ITS METALLIC ATTACHMENT RIVETS WERE REMOVED. A FLAP-ROTATION RECONSTRUCTION WAS PERFORMED ON THE SKIN. THE WOUND PUS CONTAINED STRAINS OF STAPHYLOCOCCUS AUREUS. DESPITE A BROAD-SPECTRUM ANTIBIOTIC PRESCRIBED BY THE INFECTIOUS-DISEASE PHYSICIAN FOR THE SENSITIVE BACTERIA, THE WOUND CONTINUED TO DISCHARGE PUS, AND A NEW DEBRIDEMENT PROCEDURE WAS PERFORMED, ON (B)(6) 2013, DURING WHICH AN EXTENSIVE PUS CAVITY WAS OBSERVED IN THE AREA OF THE DURA RECONSTRUCTION; THE BIOGLUE MATERIAL THAT HAD MAINTAINED THE PUS WAS REMOVED FROM THE NOW ALREADY CICATRIZED DURA RECONSTRUCTION VIA CURETTAGE. ON (B)(6) ANOTHER WOUND-DEBRIDEMENT PROCEDURE WAS PERFORMED ON ACCOUNT OF SECRETIONS FROM THE WOUND, DURING WHICH SUBCUTANEOUS TISSUES WERE REVISED AND THE WOUND WAS CLOSED. CULTURES SHOWED NO BACTERIAL GROWTH ON SAMPLES TAKEN ON (B)(6) BECAUSE OF CONTINUOUS ANTIBIOTIC TREATMENT. THE WOUND WAS OBSERVED TO BE MACERATED, AND THERE WAS A FISTULA ON THE SKIN, WHICH WAS LOCALLY TREATED. THE FISTULA WAS STILL EXCRETING PUS, AND A NEW WOUND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2013, DURING WHICH IT WAS OBSERVED THAT THE WOUND CAVITY CONTINUED ALL THE WAY TO THE UPPER PART OF THE CRANIAL-BONE OPENING AT THE LOCATION OF THE STRING BORE HOLES. THESE HOLES WERE DRILLED OPEN, AND THE CONTAINED BIOGLUE MATERIAL WAS ABLE TO BE REMOVED FROM THE HOLES. AFTER THIS, NO MORE FOREIGN MATTER WAS PRESENT IN THE WOUND. SIMULTANEOUSLY WITH THIS PROCEDURE, A PLASTIC SURGEON PERFORMED ANOTHER FLAP-ROTATION RECONSTRUCTION FOR THE WOUND. ON (B)(6) THE WOUND WAS FOUND TO HAVE HEALED WELL. [COMPUTED TOMOGRAPHY] CT SCANS OF THE HEAD WERE CONDUCTED DURING THE REVISION SURGERIES, AND ON (B)(6) 2013, MINOR ENHANCEMENT WAS DETECTED IN THE AREA WHERE CRANIAL BONE WAS RESECTED. THE SAME WAS OBSERVED IN THE SCAN FROM (B)(6) 2013, BUT NO ENHANCEMENT IN THE BONE RESECTION AREA WAS DETECTED FROM THE HEAD CT SCANS PERFORMED ON (B)(6) 2013." A REVIEW WAS PERFORMED OF POSSIBLE LOT NUMBERS 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 WOUND INFECTION OBSERVED IN THIS PATIENT CANNOT BE DEFINITIVELY DETERMINED. THE SURGEON STATED THAT THE PATIENT HAD UNDERGONE A PROCEDURE FOR A MENINGIOMA IN WHICH BIOGLUE WAS USED ALONG WITH THE PATIENT'S MUSCULAR FASCIA TO CLOSE THE DURA, AND BIOGLUE WAS USED TO CLOSE THE BORE HOLES TO PREVENT CEREBROSPINAL FLUID (CSF) LEAKAGE. BIOGLUE IS TERMINALLY STERILIZED, SO IT IS UNLIKELY THAT THE MICROORGANISMS LEADING TO THE OBSERVED INFECTION ORIGINATED FROM BIOGLUE. ALTHOUGH WE ARE UNABLE TO DEFINITIVELY DETERMINE IF AND HOW BIOGLUE PLAYED A ROLE IN THE OBSERVED WOUND INFECTION, POSSIBLE SCENARIOS INCLUDE (BUT ARE NOT LIMITED TO) THE FOLLOWING: (1) INFECTION WAS INTRODUCED DURING THE SURGICAL PROCEDURE OR DURING THE POSTOPERATIVE PERIOD AND, BECAUSE BIOGLUE CAN BE A NIDUS FOR INFECTION DUE TO THE PROTEIN CONTENT, IT CONTRIBUTED BY PROVIDING A CONTINUOUS NUTRIENT SOURCE FOR THE INFECTION; OR (2) IT IS POSSIBLE THAT THE PATIENT EXPERIENCED A FOREIGN BODY REACTION TO BIOGLUE THAT EXACERBATED THE WOUND INFECTION. OUTSIDE OF THE UNITED STATES, THE BIOGLUE LABELING INCLUDES INDICATIONS FOR SOFT TISSUE REPAIR, INCLUDING DURAL REPAIR. HOWEVER, THE USE OF BIOGLUE FOR REPAIR OF BONE DEFECTS, E.G. BORE HOLES, IS NOT INDICATED NOR HAS THIS USE BEEN STUDIED. THE CLINICAL EFFECTS OF AND DEGRADATION PROFILE FOR USE OF BIOGLUE IN BONE ARE UNKNOWN. BIOGLUE IS KNOWN TO ELICIT A FOREIGN-BODY TYPE INFLAMMATORY RESPONSE WHEN USED FOR SOFT TISSUE REPAIR. A SIMILAR TYPE OF REACTION WOULD BE EXPECTED IN BONE; HOWEVER, THE MAGNITUDE AND DURATION OF THIS RESPONSE CANNOT BE PREDICTED. A PROLONGED FOREIGN-BODY REACTION COULD POTENTIALLY HINDER THE HEALING OF AN INFECTED SURGICAL WOUND. HOWEVER, THE PRECISE RELATIONSHIP BETWEEN BIOGLUE AND THE REPORTED EVENT CANNOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO SUGGEST THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE INSTRUCTIONS FOR USE INCLUDES ADEQUATE STATEMENTS REGARDING THE APPROVED INDICATIONS FOR USE.
ACCORDING TO THE REPORT, BIOGLUE APPLIED TO ANASTOMOSIS FASCIA PATCH USED TO SEAL DURA FOLLOWING POSTERIOR FOSSA PROCEDURE. INFECTION OCCURRED IN SURGICAL AREA. PATIENT REQUIRED REOPERATION WITH BIOGLUE DETECTED IN BORE HOLES.
ACCORDING TO THE REPORT, BIOGLUE APPLIED TO ANASTOMOSIS FASCIA PATCH USED TO SEAL DURA FOLLOWING POSTERIOR FOSSA PROCEDURE. INFECTION OCCURRED IN SURGICAL AREA. PATIENT REQUIRED REOPERATION WITH BIOGLUE DETECTED IN BORE HOLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251937 | BIOGLUE SURGICAL ADHESIVE | SURGICAL ADHESIVE | MUQ | CRYOLIFE, INC. | BG35002-5-G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |