MAUDE Adverse Event Report: REVERSE MEDICAL MICROVASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	MVP-5Q
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure micro vascular plug was implanted.It was reported that the patient was discharged and sent home.Patient was told that the device had detached and was floating around inside.The mvp embolized and then migrated into the pulmonary artery.The mvp device was explanted.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway,; ste. 167; irvine CA 92618
• Manufacturer (Section G): REVERSE MEDICAL; 13700 alton parkway,; ste. 167; irvine CA 92618
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14573233
• Report Number: 3007170829-2022-00008
• Device Sequence Number: 20094032
• Product Code: KRD
• UDI-Device Identifier: 00763000307790
• UDI-Public: 00763000307790
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: MVP-5Q
• Device Catalogue Number: MVP-5Q
• Device Lot Number: 220170292
• 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: 05/05/2022
• Initial Report FDA Received Date: 06/02/2022
• Date Device Manufactured: 01/17/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Male
• Patient Weight: 6 KG