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

Model Number MVP-9Q

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A physician was attempting to use a micro vascular plug device to treat a patient.The physician had gained access into the right internal iliac artery using a non-medtronic sheath, and then used a non-medtronic 5fr.038" id to access the avm.The physician prepped the mvp-9q per the ifu, loaded the plug into the catheter with no issues.Tech assisting the doc noticed quite a bit of resistance while delivering the plug to the treatment area.Plug was about 2-3cm away from being deployed into the avm feeding vessel but would not advance past this point.Physician then re-sheathed mvp plug back into the yellow loading sheath, flushed the catheter again, and tried to advance the plug back into the 5fr catheter but the plug was stuck.It then looked like the wire attached to the plug had detached and poked a hole in the yellow loading sheath.We searched the body to make sure the plug had not detached inside the 5fr catheter, and finally found the plug inside the yellow loading sheath.The wire had become detached from the plug at the detachment zone.We proceeded to load another mvp-9q in the same 5fr catheter, and had no issues during delivery or deployment.Patient was being treated for a av malformation located in the right internal iliac area of the body.No patient injury reported for this event.

Manufacturer Narrative

Additional information: vessel tortuosity was more tortuous than normal, but not severe.  vessel was measuring 7.5mm in diameter.The physician placed plug into the heparinized saline bucket and re-sheathed the plug while the plug was still immersed in the saline.There was no twisting or rotating of the delivery wire.There was no continuous heparinized flush maintained throughout the procedure.The plug was safely removed from the patient and no vessel damage occurred due to the wire detachment.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the micro vascular plug device was returned to medtronic investigation lab for evaluation.The device was received in a bio hazard envelope.The device was coiled up inside two bio hazard bag inside the envelope.The plug was not returned.Biologics were noted on the yellow introducer sheath.No hole was noted on the yellow introducer sheath.The coating appeared to be peeling off the wire.It was observed that the wire was bent and the plug had detached.The overall length of the wire was measured, and it was approximately 163cm in length.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICROVASCULAR PLUG
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): REVERSE MEDICAL; 13700 alton parkway, ste. 167; irvine CA 92618
• MDR Report Key: 10926836
• MDR Text Key: 218936969
• Report Number: 3007170829-2020-00011
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00763000307776
• UDI-Public: 00763000307776
• Combination Product (y/n): N
• PMA/PMN Number: K150108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: MVP-9Q
• Device Catalogue Number: MVP-9Q
• Device Lot Number: B074928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1