MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has been provided.If further details are received at the later date a supplemental medwatch will be sent.(b)(4).

Event Description

Title : end-to-patch anastomosis for microvascular transfer of free flaps with small pedicle the authors reported that although perforator-to-perforator anastomosis in supermicrosurgery may be used in transferring free flaps with small vessels, it is still difficult in certain situations that include potentially infected wounds.Large vessels anastomosis is still safer for transfer of a large flap for most surgeons.The harvesting of a patch of the parent artery together with the perforator supplying the flap allows the surgeon to perform an anastomosis between the vessel ends of larger caliber, and possibly with greater anastomotic success.From 1983 to 2013, soft tissue defects in 93 patients were reconstructed with the anteromedial thigh (amt) flaps (n-7), the groin flaps (n-81), and the free becker¿s flap (n-5) using the end to-patch method by the senior author.During the procedure, considering the morbidity of the donor vessels, when a patch was acquired from the femoral artery, the size of the patch was about 1 to 1.2 mm and direct repair was performed using prolene 5-0 sutures under microscopic guidance, followed by coverage with local soft tissue.Reported complication included 1 case of bleeding from the femoral artery 2 days post-operatively due to a loose ligature at the donor-site artery which was treated by applying another suture around the femoral artery and after confirming that there was no leakage of blood from the femoral artery, soft tissue coverage with the sartorius muscle was performed.It was concluded that this end-to-patch anastomosis method can provide reliable and comfortable anastomosis when transferring a flap with small vessels.We can use this method for the other conventional classic flaps with small vessels.If there is an appropriate indication for the end-to-patch anastomosis, the only care that needs to be taken is to repair the donor artery carefully and to cover the repair site with the local tissue.

• Brand Name: PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151
• MDR Report Key: 7635974
• MDR Text Key: 112285855
• Report Number: 2210968-2018-73772
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention