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

Model Number PED-500-20

Device Problem Activation Failure (3270)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the distal end of the pipeline had trouble opening, and the proximal end of the 5mm x 18mm did not open at all even when removed, only when the device was forced off the wire that it opened.The 5mm x 20mm was still in the catheter.The pipelines were not positioned in a bend.More than 50% had been deployed when it failed to open.The pipelines were resheathed less than or equal to 2 times.The pipelines were resheathed and removed with the microcatheter from the patient.It was noted the pipelines were used for a cc fistula which was not an approved indication.The patient was undergoing surgery to treat an cc fistula at the left internal carotid artery with a distal landing zone of 4.7mm and a proximal landing of 5.2mm.It was noted the vessel tortuosity was normal.There were no patient symptoms associated with the event.The angiographic result post procedure indicated that the 5mm x 16mm pipeline worked.The patient's medical history included a previous trauma (car accident).

Manufacturer Narrative

H3: analysis of the pipeline flex pusher and braid (lot no.A900742) found that the dps sleeves were intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open at the distal and proximal ends as the distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.However, the cause for damage could not be determined.It is possible that the severe vessel tortuosity may have contributed to the failure to open issue.There was no non-conformance to specification identified that led to the failure to open issue.H6: method code updated to b01.Result code updated to c070601.Conclusion code updated to d15.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

No additional information received.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10971679
• MDR Text Key: 220916304
• Report Number: 2029214-2020-01251
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: A900742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR