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

Model Number PED-400-30

Device Problems Unintended Ejection (1234); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis of the pipeline flex embolization device (lot no.B056406) found that the braid was returned within the phenom catheter hub.The pipeline flex pushwire was found to be kinked at ~29 cm from proximal end.The hypotube was found to be stretched with the ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be missing.The tip coil was found to be missing.The proximal braid end was found to be collapsed and frayed.The distal end of braid was found to be collapsed and frayed.The phenom-27 catheter total length was measured to be ~168.2 cm (reference 166.5 cm).The phenom useable length was measured to be ~161.5 cm which is within specification (specification: 160.0 cm ± 5 cm).Upon visual inspection, no damages were found with the phenom hub; however, the pipeline flex braid was found within the hub.The braid was then removed from the hub.No bends or kinks were found with the catheter body or distal tip.The phenom catheter was then used for resistance testing.The phenom-27 catheter was tested with an in-house mandrel; however, the mandrel met resistance at ~140.5 cm from hub and was unable to exited distal tip.Based on analysis finding, the customer reports of "device opens prematurely ¿was confirmed as the pipeline flex braid was found stuck within phenom hub.There was no non-conformance to specifications identified that led to the failure to open.Based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ was confirmed as the pipeline embolization braid was returned stuck within phenom-27 catheter hub.The returned pipeline flex pushwire damages (stretched) are indicative of high force used.It is likely the damage occurred when the customer attempted to advance the pipeline flex through the phenom catheter against the reported resistance.Possible contributors for resistance are patient vessel tortuosity or lack of continuous flush during delivery.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed.Resistance can occur due to use of incompatible catheter, vessel tortuosity, failure to maintain continuous flush.Event reported in lieu of analysis results.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline experienced resistance in the distal part of the phenom 27 microcatheter and the pusher wire kinked.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the internal carotid artery.The max diameter was 10mm, and the neck diameter was 4mm.The patient's vessel tortuosity was moderate.The landing zone was 3.5mm distal and 4.0mm proximal.The access vessel was the ica, which was 5mm in diameter.It was reported that there was severe resistance while delivering the pipeline to the desired landing zone.While attempting to position the distal portion of the device into place, the pushwire bent and kinked. the proximal part of the pushwire was bent into 90 degrees.During removal, the pipeline deployed within the hub of the catheter.A continuous flush was used.The pipeline had not become stuck. angiographic results post procedure showed that the two subsequent pipelines were deployed successfully. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a phenom plus guide catheter.Additional information received reported that it was not thought the pushwire was rotated or pulled back on at any point during the procedure.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12360441
• MDR Text Key: 267897866
• Report Number: 2029214-2021-01056
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015999
• UDI-Public: 00847536015999
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2023
• Device Model Number: PED-400-30
• Device Catalogue Number: PED-400-30
• Device Lot Number: B056406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2020
• 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 Age: 77 YR
• Patient Weight: 71