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

Model Number 10621-XXXMP

Device Problems Fracture (1260); Gel Leak (1267); Patient Device Interaction Problem (4001); Air/Gas in Device (4062)

Patient Problems Rupture (2208); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

Bilateral rupture, discovered during surgery, left side; bilateral bubbling, left side and bilateral gel fracture, left side.

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra received the suspected device from the customer and performed a failure analysis.Upon initial observation the device was found to have a shell failure with no discoloration.The device was unable to be weighed.Upon device inspection, there were 4 pinholes found on the anterior side.Upon optical inspection, the explant was received ruptured and was submitted for optical analysis.An area of possible striations was identified.Optical microscope images were taken of the area.The suspected cause of the shell failure is surgical instrument damage.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Sientra complaint #: (b)(4).Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

Bilateral rupture, discovered during surgery, left side; bilateral bubbling, left side; bilateral gel fracture, left side and bilateral physical asymmetry, left side.

• 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: 18046336
• MDR Text Key: 327026847
• Report Number: 1651189-2023-05795
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10621-XXXMP
• Device Catalogue Number: 10621-325MP
• Device Lot Number: A17820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 10/31/2023
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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: 73 YR
• Patient Sex: Female