MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS GEM FLOW COUPLER DEVICE AND SYSTEM; ANASTOMOTIC COUPLER AND FLOW METER

Device Problem Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

"free flap monitoring using an implantable anastomotic venous flow coupler: analysis of 119 consecutive abdominal-based free flaps for breast reconstruction" microsurgery 2014.Retrospective data were collected on patients undergoing free flap breast reconstruction from may 2012 to march 2014.The venous anastomotic flow coupler was used in the first 85 flaps and a non-flow coupler with clinical and external doppler monitoring alone int he subsequent 34 flaps.The authors report incidences of vessel thrombosis, flap take back, flap failure, device failure, and wire kinking vessel.No additional information is available.It cannot be concluded whether the flow-coupler or coupler was a contributing factor in these events.This report is for the four (4) incidences of flow-coupler related wire kinking vessel.All 4 cases had return of blood flow with intraoperative repositioning or re-inset of the flap.There were no flap losses in these cases.

Manufacturer Narrative

The product is not available for evaluation.A review of the device history record was not possible since the lot number was not available.There were zero device coupling problems reported and the flow-coupler was 100% sensitive in detecting flap compromise in both the intra- and postoperative settings.Flow-coupler related flap take back and flow-coupler related flap failure were previously reported in mfr report # 2183620-2014-00003 and 2183620-2014-00004.All medwatch reports for this article include: 2183620-2014-00003, 2183620-2014-00004, 2183620-2014-00019, 2183620-2014-00020, 2183620-2014-00021, 2183620-2014-00022.Journal article: kempton, s.J., poore, s.O., chen, j.T., & afifi, a.M.(2014).Free flap monitoring using an implantable anastomotic venous flow coupler: analysis of 119 consecutive abdominal-based free flaps for breast reconstruction.Microsurgery, advance online publication.Doi 10.1002/micr.

• Brand Name: GEM FLOW COUPLER DEVICE AND SYSTEM
• Type of Device: ANASTOMOTIC COUPLER AND FLOW METER
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w.; st. paul MN 55114
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w.; st. paul MN 55114 102
• Manufacturer Contact: scott johnson ; 2575 university ave. w.; st. paul, MN 55114-1024 ; 6517967334
• MDR Report Key: 4321784
• MDR Text Key: 5243976
• Report Number: 2183620-2014-00020
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1