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

Model Number PED2-400-16

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the doctor went up with the phenom and avigo microguide, positioned themselves in the anterior cerebral artery and removed the microguide, raised the pipeline device and began to release it in the paraophthalmic segment.The diver opened in its distal portion; however, when it was going through the segment in the middle, the device did not open so the doctor re-sheathed the device and tried to free it again without success.When they tried to recapture the entire device to rearrange it, they only entered the guide wire in the microcatheter, leaving half of the pipeline in the vessel out of it.They tried to retract the microcatheter and push the guide wire to deploy the mesh, but the device's release system was detached.The guide wire was advancing alone without deploying the mesh.They tried to resheath it without success.The doctor decided to raise the navien catheter to rescue the device with half of the pipeline that was left outside the microcatheter, successfully removing the entire system.The event lead to or extended the patient's hospitalization for approximately 10 days.Dapt (dual antiplatelet treatment) was administered, and the patient's pru level was 140.Angiographic result post procedure was normal.The patient was undergoing surgery to treat an unruptured, fusiform aneurysm located at the right ophthalmic carotid artery with a max diameter of 3 mm and a neck diameter of 3 mm.It was noted the vessel tortuosity was minimal.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.There was no friction or difficulty during positioning.

Manufacturer Narrative

B5 updated with additional information.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.

Event Description

Additional information received reporting that the middle section of the device that failed to open was positioned in a vessel bend.

• Brand Name: PIPELINE FLEX W/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: 10826816
• MDR Text Key: 217325711
• Report Number: 2029214-2020-01121
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: B015311
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Weight: 55