MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV VRV100 MEDTRONIC OVERPRESSURE RELIEF VALVE; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	9156R2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during use of a medtronic overpressure relief valve, it was reported that the device appeared to function normally for the first 10 minutes of use, however, after this period of time blood began to leak out of the side of the valve.The leakage largely occurred when the vent was off.The use of the device was unspecified.It was unknown if there was any adverse patient effects associated with this event.
Additional Manufacturer Narrative
Additional information b5: the device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was very little patient blood loss as a result of this leak.No transfusion was required.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Device evaluation: visual inspection showed no outward signs of any damage.The device had a test mark, which confirmed the vrv was tested prior to distribution.Functional testing of the returned device was performed at 0.5 l/min.The instructions for use provides an approximation for first time use of negative and positive pressures to open the umbrella relief valves at 0.5 l/min blood flow are approximately -205 mmhg and 318 mmhg.The results indicated the negative pressure umbrella opened at -179 mmhg and the positive pressure umbrella valve opened at 323 mmhg verifying the functionality for the valves for the returned device.The acceptable function of the umbrella valves also confirms the duck bill valve functioned as intended.There was no leaking observed.Conclusion: reason for the return was not confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VRV100 MEDTRONIC OVERPRESSURE RELIEF VALVE
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23679145
• Report Number: 9617601-2025-03077
• Device Sequence Number: 10401967
• Product Code: DWE
• UDI-Device Identifier: 00673978558455
• UDI-Public: (01)00673978558455(17)270321(10)228382979
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K973011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9156R2
• Device Catalogue Number: 9156R2
• Device Lot Number: 228382979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 02/12/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/02/2025; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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
• Patient Sex: Unknown