MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION - ROSWELL ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE; CANGAROO RM ANTIBACTERIAL ENVELOPE

Model Number	CMCV-124-LRG
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Notification was received from boston scientific sales representative that an 84 yr.Old male patient was implanted with an abbott biventricular icd generator (change-out) on (b)(6) 2026 using an elupro antibiotic-eluting bioenvelope (cmcv-124-lrg; lot#: m26c1083).It was reported that the patient had developed a seroma and upon physician evaluation of the pocket, the device was explanted on (b)(6) 2026.Cultures taken during the explant procedure were negative for bacteria presence.The physician states that the reported seroma is related to the elupro bioenvelope and not procedure related.No further details are available regarding the reported event, should any additional information be received, a follow-up report will be submitted.
Additional Manufacturer Narrative
Manufacturing review of the elupro antibiotic-eluting bioenvelope device history record was completed resulting in no quality issues identified during processing of the final packaging, or the sterile subassembly manufacturing lots.It is noted that per the instructions for use (ifu - art-20837 rev.A, ifu elupro antibiotic-eluting bioenvelope) provided with each finished elupro device, that "seroma" is a potential known complication associated with the use of the elupro bioenvelope or any cardiac surgical implant procedure.The information provided by the reporting physician states the reported seroma as being a result of the usage of the elupro bioenvelope device.No other details are available, should any additional information be received a follow up report will be filed.

• Brand Name: ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE
• Common Device Name: CANGAROO RM ANTIBACTERIAL ENVELOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION - ROSWELL; 1100 old ellis road; suite 1200; roswell GA 30076
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION - ROSWELL; 1100 old ellis road; suite 1200; roswell GA 30076
• Manufacturer Contact: courtney payne ; 1100 old ellis road; suite 1200; roswell, GA 30076
• MDR Report Key: 25610884
• Report Number: 3005619880-2026-50005
• Device Sequence Number: 21282599
• Product Code: FTM
• UDI-Device Identifier: 00859389005348
• UDI-Public: 00859389005348
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K233991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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 Model Number: CMCV-124-LRG
• Device Lot Number: M26C1083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2026
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male