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

Model Number MVP-9Q

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Occlusion (1984)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the medtronic plug encountered difficulties detaching.Once it detached, it migrated and failed to occlude the intended vessel.A different plug was implanted to seal the vessel off completely.Additional information was required to determine the cause of the event.The hcp was contacted for additional information and response was received.As the device remained in the patient and the pushwire was disposed of; therefore, no analysis could be performed.There was no indication that the event was related to a potential manufacturing issue and no dhr was requested, so a device history record review was not performed.The investigation determined that this was a known event, and therefore no new formal investigation was required.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the medtronic plug encountered difficulties detaching.Once it detached, it migrated and failed to occlude the intended vessel.Prior to the event, the plug was positioned in the desired location and then attempt to detach was made but physician felt that there was no detachment and seemed like the plug did not oppose the vessel wall possibly due to inappropriate size or flared vessel.Once the plug detached, it travelled further a few centimeters.Since there was not complete occlusion, a similar amplatzer 12 was placed to seal the laii completely.Since purpose of the plug was to occlude the vessel, there was no harm in patient.The patient's vasculature was minimal in tortuosity.

• Brand Name: MICROVASCULAR PLUG
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): REVERSE MEDICAL CORPORATION; irvine CA 92618
• Manufacturer (Section G): REVERSE MEDICAL CORPORATION; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8696732
• MDR Text Key: 147928405
• Report Number: 3007170829-2019-00003
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K150108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: MVP-9Q
• Device Lot Number: A534200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2019
• Date Device Manufactured: 10/04/2017
• 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
• Patient Age: 70 YR
• Patient Weight: 85