MAUDE Adverse Event Report: SIENTRA INC SIENTRA SILICONE GEL BREAST IMPLANTS

Model Number 10512-XXXMP

Device Problems Positioning Failure (1158); Gel Leak (1267); Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Rupture (2208); Ptosis (2620); Insufficient Information (4580)

Event Date 07/20/2023

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra was unable to perform an evaluation as the device was discarded by the customer.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device discarded.

Event Description

Right implant ruptured, discovered during surgery; bilateral malposition, right side (doe: (b)(6) 2023); bilateral ptosis grade 3, right side (doe: (b)(6) 2023); and patient claim breast implant illness, symptoms: loss of energy, always feeling tired (doe: (b)(6) 2023).

• Brand Name: SIENTRA SILICONE GEL BREAST IMPLANTS
• Type of Device: SILICONE GEL BREAST IMPLANT
• Manufacturer (Section D): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer (Section G): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 17508849
• MDR Text Key: 320868378
• Report Number: 1651189-2023-05304
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: 10512-XXXMP
• Device Catalogue Number: 10512-210MP
• Device Lot Number: 4378938
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2013
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female