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

Model Number 20610-XXXLP

Device Problems Calcified (1077); Gel Leak (1267); Patient Device Interaction Problem (4001)

Patient Problems Calcium Deposits/Calcification (1758); Capsular Contracture (1761); Rupture (2208)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Sientra complaint #: (b)(4).Investigational device [ide], no expiration date or date of manufacture available.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

Mri indicated bilateral rupture, right side, capsular contracture, baker grade unknown, side unknown and bilateral implant calcification, right 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: 18793241
• MDR Text Key: 336375354
• Report Number: 1651189-2024-06513
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20610-XXXLP
• Device Catalogue Number: 20610-310LP
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/22/2024
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 43 YR
• Patient Sex: Female