MAUDE Adverse Event Report: TEPHA, INC. - 3005670760 GALAFLEX; ABSORBABLE MESH

Catalog Number	GP0608
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Breast Cancer (1759)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient was diagnosed with pre- cancer/ductal carcinoma in-situ event in the right breast three years post implantation of galaflex in the left breast.There is no indication that the condition found is in any way related to the use of the p4hb implant in the left breast.As relatedness cannot be completely ruled out an mdr is filed to document the event.Review of manufacturing records shows product was manufactured to specification.Not returned.
Event or Problem Description
It was reported that in 1994 a female patient with a medical history of breast cancer, mastectomy underwent left breast reconstruction with a silicone implant and an augmentation implant on right breast.Over the next 24 years she developed progressive asymmetry.On (b)(6) 2018, the patient underwent revision surgery, during which both the silicone implants were removed, and implant of galaflex p4hb on the left reconstruction side only.The patient underwent mastopexy on right breast and three fat graft surgeries over the next year and a half.At the end of 2022, the patient was diagnosed with the micro calcifications and 4 mm pre-cancer (ductal carcinoma in-situ) in right breast.On (b)(6) 2022, the patient underwent right mastectomy and diep flap reconstruction and silicone tissue expanders were placed bilaterally.Her surgery went well.The path report showed no sign of cancer remaining after the needle biopsy.As reported, the implanting surgeon did not consider the pre-cancer ductal carcinoma occurrence right breast to be an outcome of the use of galaflex in the left breast and was reported in an abundance of caution to document the event.

• Brand Name: GALAFLEX
• Common Device Name: ABSORBABLE MESH
• Manufacturer (Section D): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer (Section G): TEPHA, INC. - 3005670760; 99 hayden ave suite 360; lexington MA 02421
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16277294
• Report Number: 1213643-2023-00035
• Device Sequence Number: 12392593
• Product Code: OOD
• UDI-Device Identifier: 00855920006041
• UDI-Public: (01)00855920006041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2023

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: 12/31/2020
• Device Catalogue Number: GP0608
• Device Lot Number: 180150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female