MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Impaired Healing (2378); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an anterior talofibular ligament /atfl reconstruction procedure on (b)(6) 2016 and the suture was used.Following the procedure, the wound would not heal and it became infected.It was also reported that the patient's body was rejecting the suture and the suture was popping through the skin.The patient was sent to emergency and was opened up again to install a vacuum on her ankle for a week before closing it up.After several weeks, the wound did not heal and now it became extremely painful to put her leg down.The patient was diagnosed with complex regional pain syndrome, crps or amps.The doctor opines that crps was the root cause of the pain and lack of perfusion to the wound.As reported, a doctor performed a lower lumbar nerve block per crps protocol and must have missed the spot because it made the patient frozen in pain in her back and hip.The patient had to use a wheelchair and to be carried to bathroom for two weeks.It was also reported that the patient was admitted to the specialized hospital two weeks ago and she is there for at least another month.At this hospital, the patient undergoes a physical therapy/pt , walking through 8-9 hours daily.Additional information will be requested.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6300418
• MDR Text Key: 66474848
• Report Number: 2210968-2017-30597
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• 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?: No
• Date Manufacturer Received: 01/16/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 14 YR