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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES
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CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES Back to Search Results
Model Number BG3502-5-US
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Tingling (2171)
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Event Description
According to the initial report,"i received a call from a plastic surgeon that used bioglue for a facelift procedure.The patient has a complaint of a mass under her skin that has presented post-op.The surgeon was inquiring if the application of bio-glue was responsible." additional information received relays the plastic surgeon used the bioglue for a facelift procedure on both sides of face to adhere flaps.The patient came in for follow up two months post operatively complaining of mass.The patient's left side of face developed a mass postoperatively along suture line where bioglue was used.No intervention has been performed.Per a phone conversation on (b)(6) 2019 between the plastic surgeon and cryolife's medical director, it was discussed how the plastic surgeon could best remove the bioglue mass.The patient has reported pain, tingling and loss of feeling where the bioglue mass is located.The plastic surgeon dosen't remember the amount of bioglue used, but stated that half of the syringe was used on one side of the face and the other half was used on the patient's other side of face.Cryolife's medical director relayed that bioglue is used for large vessel anastomosis, and the use of bioglue during a facelift is an off label use.Cryolife's medical director also answered the plastic surgeon's question if the bioglue will go away (dissolve).Cryolife's medical director responded that it can take months up to 1 year before the bioglue will be reabsorbed.The plastic surgeon is planning to schedule the patient very soon for surgery to remove the bioglue mass.
 
Event Description
According to the initial report, "i received a call from a plastic surgeon that used bioglue for a facelift procedure.The patient has a complaint of a mass under her skin that has presented post-op.The surgeon was inquiring if the application of bio-glue was responsible." additional information received relays the plastic surgeon used the bioglue for a facelift procedure on both sides of face to adhere flaps.The patient came in for follow up two months post operatively complaining of mass.The patient's left side of face developed a mass postoperatively along suture line where bioglue was used.No intervention has been performed.
 
Manufacturer Narrative
The manufacturing records for lot number 18euv006 were reviewed.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.The use of bioglue as defined in the case report for a facelift procedure is no an approved indication in the united states.As stated in the ifu¿s indications for use,¿bioglue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral, and carotid arteries)¿.The doctor mentioned not knowing how much bioglue he used in the procedure, using one half of the syringe for one side of the face and the other half on the other side.This may have been excessive use of the product.Bioglue degrades via proteolysis, and dependent upon how much product was used it can be slow to absorb.Listed as a warning in the ifu, ¿the slow resorption of excessive amounts of bioglue has been associated with sterile inflammatory response requiring explant of the material.Bioglue should be applied in a thin layer, as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess.¿ it is probable that bioglue is the cause of the mass on the patient¿s left side of face given the excessive amount of bioglue potentially used to ¿adhere flaps¿ during the facelift procedure.The use of bioglue in this case report is considered an off-label use.Using bioglue for a facelift procedure is not an approved indication.The ifu states that bioglue is indicated for use as an adjunct to sutures or staples in open surgical repair of large vessels and should be applied in a thin layer.It also warns that excessive amounts of bioglue have been associated with sterile inflammatory response with the need to explant the product.No further action required.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.
 
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Brand Name
BIOGLUE SURGICAL ADHESIVE
Type of Device
GLUE, SURGICAL, ARTERIES
Manufacturer (Section D)
CRYOLIFE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
MDR Report Key8608601
MDR Text Key144997930
Report Number1063481-2019-00028
Device Sequence Number1
Product Code MUQ
Combination Product (y/n)N
PMA/PMN Number
P010003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date10/10/2019
Device Model NumberBG3502-5-US
Device Catalogue NumberBG3502-5-US
Device Lot Number18EUV006
Was Device Available for Evaluation? No
Distributor Facility Aware Date04/30/2019
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO INFORMATION; NO INFORMATION
Patient Outcome(s) Other; Required Intervention;
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