MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH FORTIVA PORCINE DERMIS; SURGICAL MESH - PORCINE DERMIS

Lot Number PD18100001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The graft remains implanted.Therefore, our investigation is based on a comprehensive records re-review.Once the results of investigation are available, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a complaint on 09/28/2020, as part of the fortiva appear trial.The reported complaint indicated that on (b)(6) 2020, a (b)(6) year old female patient underwent a right sided nipple conserving inframmary mastectomy due to stage ia breast cancer.A silicone implant was placed and a fortiva porcine dermis was implanted.Four lymph nodes were removed.Two drains were placed, one in hte axilla and one in the breast.The drains were removed on (b)(6) 2020 when fluid drainage was less than 30cc/day and the patient was discharged home without medications.On (b)(6) 2020, the patient developed a seroma requiring multiple drainings that did not require hospitalization.It was reported that this event was considered resolved on (b)(6) 2020.

Manufacturer Narrative

Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot pd18100001.One departure from the standard operating procedures was noted during the records re-review for the lot (alerting deep freezer (no.950) - no impact on the product as the tissue was restored immediately in another freezer and the temperature was constantly -40°c.Manufacturing records review indicated that serial id (b)(6) was manufactured to specification and met all acceptance / inspection criteria prior to distribution.To date, rti germany has manufactured and distributed a total of 51 fortiva® 1mm perforated xenografts from the lot.There are six related complaints associated with lot pd18100001 and the fortiva appear trial (reference complaints (b)(4).Although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.Seroma formation has frequently been reported to occur post-operatively, especially when lymphatic vessels have been cut.Seroma formation may also be caused by decreased blood supply at the surgical site, poor soft tissue coverage, and/or high activity level post-operatively.Often drains are placed during the surgical procedure to prevent seroma formation.The surgical procedures (mastectomy and breast reconstruction) and/or placement of the silicone implant could be considered a confounding factor to seroma development.In this specific case, two drains had been placed and four lymph nodes were removed on the right side.It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implant.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: SURGICAL MESH - PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrabe 6; neunkirchen am brand, 97077 ; GM 97077
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 10751976
• MDR Text Key: 214828437
• Report Number: 3002924436-2020-00017
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: PD18100001
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female