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

Model Number	100035-09
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Breast Cancer (1759)
Date of Event	11/26/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
As reported, the patient was diagnosed with breast cancer occurrence post-implant of galaflex.The surgeon did not identify any causal relationship between the cancer and the galaflex implant used to treat the patient.In an abundance of caution, events for which relatedness cannot be completely ruled out are processed for mdr reporting.Review of manufacturing records shows product was manufactured to specification.Note: this mdr represents device 1.The information associated with device 2 used to in the revision procedure to treat the patient, in which a cancer recurrence presented was previously reported as mdr 1213643-2022-00604.The use of device 1 in an earlier surgery to treat the patient is recently obtained information.Information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported on (b)(6) 2018 patient underwent removal of silicone implants, complete capsulectomy, internal and external mastopexy, lotus scaffold implant and autologous fat transfer to bilateral breasts from abdomen and thighs.As reported galaflex 15.3cm x 20.3cm mesh (device 1) was used to create the scaffold.On (b)(6) 2019, patient was identified with right breast invasion ductal carcinoma (cancer occurrence) (er neg pr neg her-2 neg (ki-67 78%, ck-5 15%).On (b)(6) 2019, patient underwent skin and nipple sparing mastectomy of the right breast with immediate reconstruction with internal mastopexy and p4hb lotus mesh implant.As reported galaflex 15.3cm x 20.3cm mesh (device 2) was used to create the scaffold.On (b)(6) 2020 mass subdermal at ¿t¿ felt by physician.On (b)(6) 2020 excisional biopsy done and pathology on 6/19/2020 showed recurrence of breast cancer.On (b)(6) 2020 patient passes away from triple negative breast cancer.

• Brand Name: GALAFLEX
• Common Device Name: BREAST - 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: 15631493
• Report Number: 1213643-2022-00660
• Device Sequence Number: 18136349
• 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): 10/14/2022

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 Model Number: 100035-09
• 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: 09/21/2022
• Initial Report FDA Received Date: 10/19/2022
• 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: Death; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG