MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN MAE DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number MAE UNK DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Seroma (2069)

Event Type  Injury  

Event Description

B.D.Nguyen-sträuli; vorburger, d; frauchiger-heuer, h; bringolf, l; maggi, n; dedes, k.J talimi-schnabel, j; prepectoral implant-based breast reconstruction with tiloop®bra pocket ¿ a single-centre retrospective study; journal of plastic, reconstructive & a esthetic surgery 75; doi.Org/10.1016/j.Bjps.2021.08.0.Background: prepectoral implant-based reconstruction using synthetic meshes is feasible with good outcomes.We present our data using tiloop®bra pocket, a novel ready-to-use mesh pocket which acts asan internal bra and prevents the implant from dislocating or twisting.Methods: a single-centre retrospective cohort study was performed to assess short-term complication rates and cosmetic outcomes in patients with prepectoral implant- based reconstruction using the tiloop®bra pocket.The primary endpoint was complication rates during the first 6 months.The secondary endpoint was the cosmetic outcome after 6 to 12 months, which was judged by two breast surgeons using the harvard score.Results: a total of 63 breasts (43 patients) were reconstructed using the tiloop®bra pocket between 2018 and 2020, 57 were immediate reconstructions.The overall complication rate was 30,2% (n = 19/63).Major complications occurred in seven breasts (n = 7/63; 11,1%) and minor complications occurred in 12 breasts (12/63; 19,0%).The unplanned revision rate was 12,7%.The cosmetic outcome was good (harvard score: mean 3, range 1¿4; sd 0,75).Seventeen cosmetic complications were observed (17/63; 27,0%) and six cosmetic revision surgeries were performed (6/63; 9,5%).Conclusion: the use of the tiloop®bra pocket is convenient and standardized because the pocket is preformed and does not require to be sewn first.Cosmetic outcome is good; however, the surgical morbidity needs to be addressed in future reconstructions.Careful patient selection and preparation techniques are vital in order to achieve acceptable complication rates and satisfying cosmetic results.Reported events: according to the literature, the authors reported use of plasmablade in mastectomy.Complications such as seroma, hemorrhage, infection, wound-healing deficiencies was experienced.Two hemorrhagic events were recorded, all of them needing surgical evacuation.

Manufacturer Narrative

The unique identifier was not known at the time of reporting.No parts have been received by the manufacturer for evaluation.The manufacture date was not available at the time of reporting.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN MAE DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13792226
• MDR Text Key: 292502634
• Report Number: 1226420-2022-00013
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K073057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK DEV
• Device Catalogue Number: MAE UNK DEV
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: No
• 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