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 Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Immune System Problem (4435)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
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 lot.It is noted that per the instructions for use (ifu - art20837 rev.A, ifu elupro antibiotic-eluting bioenvelope) provided with the finished elupro device, "infection" and "allergic reaction or hypersensitivity to ecm, antibiotic(s) or suture" is listed within the potential complications associated with device usage.Infection and allergic reaction are known complications with the implant of a cardiac implantable device for cardiac surgical procedure.It should be noted that irrisept is not listed in the ifu as a recommended hydration solution.The information provided by the clinical site implies that there was a possible allergic reaction possibly caused by the elupro device, and that the infection was probably related to the cardiac surgical procedure; therefore it cannot be determined if the device alone was the cause of the adverse event(s).No other details are available, should any additonal information be received a follow up report will be filed.
Event or Problem Description
A 75-year-old male patient was implanted with an elupro device (cmcv-124-lrg, large, m25g1163) on (b)(6) 2025 with a biotronik acticor 7 vr-t dx icd by the implanting physician.This patient is subject (b)(6) enrolled in the post-market clinical study, elupro antibiotic-eluting bioenvelope registry study.A combination of saline and irrisept were utilized to rehydrate the device for 35 seconds.Use of irrisept as a hydration solution was noted.No concerns or complaints were noted during or after the completion of the implantation procedure.On (b)(6) 2025, the patient was reported to have a possible infection which was reported as probably related to the procedure; and a possible allergic reaction which was noted as possibly related to the elupro device.The patient was prescribed 100mg of doxycycline.The infection has not yet been confirmed, and the event in the clinical report is listed as ongoing.
Additional Manufacturer Narrative
Additional information received from site 06apr2026 requiring follow-up and correction: b5: on (b)(6) 2025, the patient presented at wound check visit, erythema was noted and 100mg (x 10 days) prescribed due to concern for possible infection versus allergic reaction.On (b)(6) 2025, patient returned for follow-up, at which time no signs of possible infection were present.Event was updated to be resolved without sequelae.H6 (e): added erythema to health effects.

• Brand Name: ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE
• Common Device Name: CANGAROO RM ANTIBACTERIAL ENVELOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION - ROSWELL; 1100 old ellis rd.; ste. 1200; roswell GA 30076
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION - ROSWELL; 1100 old ellis rd.; ste. 1200; roswell GA 30076
• Manufacturer Contact: courtney payne ; 1100 old ellis rd.; ste. 1200; roswell, GA 30076 ; 8882721001
• MDR Report Key: 24780597
• Report Number: 3005619880-2026-50002
• Device Sequence Number: 12295465
• Product Code: FTM
• UDI-Device Identifier: 00859389005348
• UDI-Public: 00859389005348
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Expiration Date: 03/20/2026
• Device Model Number: CMCV-124-LRG
• Device Lot Number: M25G1163
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White