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

Model Number PED-350-12

Device Problem No Apparent Adverse Event (3189)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

See manufacturer report # 2029214-2021-00749 for another pipeline involved in this event.No flash or voids molded were found within the phenom-027 micro catheter hub.No damages or anomalies were found with the hub, catheter body, distal tip or marker band.The pipeline flex pusher was extending out the hub ~38.0cm.No damages were found with the pipeline flex proximal pusher.The hypotube was intact and unstretched and ptfe shrink tubing was found undamaged.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The distal wire was found bent at the resheathing pad.The distal delivery wire was found broken distal to the resheathing pad.The dps sleeves, dps restraints and tip coil were not returned for analysis.The broken distal wire was sent out for sem analysis.Sem result: the wire exhibit significant corrosion damage.No original fracture features are visible.Based on the analysis findings, the customer report of ¿device opens prematurely¿ could not be confirmed through device analysis.Possible causes for failure are resistance during delivery, high force delivery, operator did not have the sheath properly seated in hub of microcatheter, over-manipulation, pushwire was torqued/pulled back during insertion or advancing ped inside microcatheter, or user resheaths device more than two times.The pusher was found bent at the resheathing pad, potentially contributing towards the premature open.As the braid was not returned for analysis, any contribution of the braid towards the premature open could not be assessed.The distal wire was found broken.Possible contributors towards pushwire breaks are patient vessel tortuosity, excessive force, resistance during delivery/retrieval, over-manipulation, or user resheaths more than 2 times.This event is similar to a previous investigation and a new investigation is not required.There was no non-conformance to specifications identified that led to the reported issues.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline pushwire that was thought to have separated.The patient was undergoing a procedure for flow diverter treatment of an unruptured saccular aneurysm in the left internal carotid artery (ica).The aneurysm max diameter was 3mm and the neck diameter was 2mm.Vessel tortuosity was minimal.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).During deployment of the pipeline, the physician felt that the pushwire detached from the device so it was decided to recapture the pipeline and start over.It was noted there was no friction or other difficulty but thought the pushwire may have been damaged.Another pipeline was implanted successfully.There was no harm or injury to the patient.Ancillary device: phenom 27 microcatheter additional information received indicated there was no pushwire break or apparent damage.The device seemed to disconnect from the pushwire.

• 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: 12620589
• MDR Text Key: 281211074
• Report Number: 2029214-2021-01267
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015272
• UDI-Public: 00847536015272
• 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
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2023
• Device Model Number: PED-350-12
• Device Catalogue Number: PED-350-12
• Device Lot Number: B131340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR