MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED3-027-600-50

Device Problems Positioning Failure (1158); Unintended Ejection (1234); Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the giant aneurysm had been previously treated with a pipeline device, coils, and a solitaire ab (sab) device.Navigation distal to the intended landing zone was difficult as it was passing through two existing stents.The process involved multiple catheter exchanges and a balloon.Approximately two hours had elapsed.The phenom was tracked beyond the intended landing zone distal to the markers of the sab stent.The location was distal to the ophthalmic artery origin.The vantage device was opened in the ophthalmic artery segment  (c6) and dragged back into the existing sab.The stent landed in the c5/distal c4 segment.Proper wall apposition around the cavernous bend was not achieved.The physician continued to deploy the device, and it expanded with some manipulation until reaching the proximal marker of the sab.The proximal end of the sab was at the proximal c3 and distal c 2 segments, the vantage looked like an hourglass shape: opened distal and proximal to this location.The physician attempted to recapture the vantage device, however, the microcatheter jumped forward and the stent inverted into itself.The tip coil had come back significantly and detachment occurred.Attempts to pass through the inverted stent segment was unsuccessful.The physician proceeded to balloon the segment several times.Post angioplasty, there was still no access beyond this point, and the procedure was terminated.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery (ica) with a max diameter of >20 mm and a >10 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, the platelet reactivity units (pru) level was unknown.It was reported the pipeline was used for an off-label indication: aneurysm previously treated with a pipeline and solitaire ab placed inside of it.Ancillary devices include a neuron max 088 80cm, neuron max 088 90cm, navien 072 first,  navien 058 115cm, phenom 027, asahi wire 300cm, traxcess 14 wire, scepter balloon.

Event Description

Additional information received reported there was no plan for further intervention.The patient was discharged from the hospital with no neurological deficit.

Manufacturer Narrative

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.

• Brand Name: PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12223301
• MDR Text Key: 263389408
• Report Number: 2029214-2021-00919
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-600-50
• Device Catalogue Number: PED3-027-600-50
• Device Lot Number: B188961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1