MAUDE Adverse Event Report: POLYGANICS INNOVATIONS BV VIVOSORB; VIVOSORB SHEET

Model Number	FS01-035/20
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for investigation.The device was released according to specification.As the surgeon indicated, the patient group might be of influence in the results: prior to the study, the device was already used in dupuytren patients successfully.However, the cases within the study seem to be more severe with regards to disease symptoms, surgical intervention and/or postoperative training regimen, which might be (one of) the reasons causing the adverse events.In addition, the device was placed very near to the surface of the wound bed, which might lead to higher risk for protrusion due to the limited soft tissue covering the device.The surgeon is currently investigating the cases and results to be able to identify the cause of the adverse events.
Event or Problem Description
A post-market investigator-driven trial is currently performed (an academic prospective interventional cohort study with patients suffering dupuytren disease) with minimal invasive surgery and vivosorb in order to improve deformity of the finger.This is within the scope of the vivosorb intended use.At the 2-week follow-up visit, two patients experienced protrusion of (part of) vivosorb.Limited information from one patient only has been obtained, see below: surgery begin (b)(6) 2020.Vivosorb was cut into pieces; placed on multiple locations and fixated with sutures in the palm of the hand, very close under the skin and near the wound bed.At the 2-weeks follow-up after surgery (b)(6) protrusion occurred from a part of the vivosorb; patient picked at the wound and pulled loose pieces of product.The surgeon cleaned the wound bed, removed remnants of vivosorb, and closed the wound.The other pieces of vivosorb are still in place.

• Brand Name: VIVOSORB
• Common Device Name: VIVOSORB SHEET
• Manufacturer (Section D): POLYGANICS INNOVATIONS BV; rozenburglaan 15a; groningen, groningen 9727D L; NL 9727DL
• MDR Report Key: 10064803
• Report Number: 3004504732-2020-00001
• Device Sequence Number: 16337759
• Product Code: FTL
• UDI-Device Identifier: 08717703990201
• UDI-Public: 08717703990201
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2020
• Device Model Number: FS01-035/20
• Device Catalogue Number: FS01-035/20
• Device Lot Number: FSA2018040412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention