MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION; GLUE, SURGICAL, ARTERIES

Model Number BG UNK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969)

Event Type  Death  

Event Description

Publication, ¿surgical results and usefulness of biological glue for ventricular septal perforation/left ventricular rupture,¿ by uchida k et al., reported the following: 31 total cases (20 vsp, 11 cases of lvfwr) with 28 cases using grf and 2 using bioglue for repair.Operation results for 20 vsp cases: no deaths for 30 days and 4 cases of in-hospital deaths (20%).Cause of deaths included 1 case of vsp recurrence after 1 month, 1 case of mr heart failure due to papillary muscle failure, and 2 cases of elderly cognitive dysfunction.Residual short shunt in 6 cases (30%), reoperation in 2 cases (10%).Cardiac death avoidance rate was 5 years (80%) and 10 years (70%).Operation results for 11 lvfwr cases: 10 cases successful in hemostasis, 1 failed resuscitation.4 deaths in 30 days (40%): 1 case of resuscitation failure, 1 case of hypoxic brain death, 1 case of heart failure, and 1 case of cerebral infarction.Death avoidance rate at 5 years was 36%, with heart failure recognized in 3 cases.The authors conclude that the ¿use of biological glue for necrotic myocardium seems to be safe and useful¿.However, those patients with extensive myocardial infarction, cardiac failure may be uncontrollable even with the surgical treatment.The article does not specify which glue (grf or bioglue) may have contributed to the following adverse events: reoperation, death.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11390922
• MDR Text Key: 233945613
• Report Number: 1063481-2021-00011
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P01003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other