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

Model Number PED2-300-10

Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that a pipeline shield had difficulty unsheathing and deploying, resistance, and failure to open.The patient was being treated for a bi-lobed unruptured aneurysm in the m1-m2 location.The max diameter was 3cmx 4 cm.The neck diameter was 2.3 mm.The distal landing zone was 3.2 mm and the proximal landing zone was 3.9 mm.Vessel tortuosity was normal.  extreme difficulty unsheathing and deploying the pipeline.Normal anatomy, prepped per instructions for use (ifu), standard technique used by experienced physician.An abundance of resistance. stuck (locked up) in catheter or resistance in catheter.The pipeline became stuck in the distal section of the catheter and became stuck during deployment.The physician released to load in the system and the issue did not resolve.The pipeline failed to open distal.The pipeline was not in a bend.Less than 50% of the pipeline had been deployed.The pipeline was resheathed less than or equal to 2 times.The pipeline was removed with the microcatheter and the was movement during placement (difficult placement/positioning).Multiple devices were not being used when movement occurred.Friction during delivery was severe.The pipeline was not implanted at the intended location.The pipeline did not miss the landing zone or jump during deployment.The pipeline was placed at least 3 mm past the aneurysm neck on each side.No side branches were covered by the pipeline.The tip of the catheter was not moved during deployment. dapt (dual antiplatelet treatment) was administered at pru level 118.Angiographic result post procedure was successful aneurysm occlusion.No symptoms were reported.  ancillary device: bmx96 sheath, phenom27 and phenom17 microcatheter , axium 4x6 and axium 3x6 coils.

Manufacturer Narrative

The pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex pusher was found extending out from within the phenom 27 catheter hub for 39.0cm.The pipeline flex braid was found partially deployed out from within the phenom 27 distal tip.The phenom 27 distal tip was found bent/kinked.The pipeline flex device was pushed out from within the phenom 27 catheter with resistance.Dried blood was noted on the pipeline flex pusher which likely contributed to the resistance.The pipeline flex pusher was intact.The pusher shrink tubing was found pulled back from the proximal bumper and the pusher was found bent at the resheathing pad.The pipeline flex braid ends were found open.Dried blood was noted within the braid proximal end.The braid¿s proximal end was found in good condition; however, the distal end was found damaged (frayed).Based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report was confirmed as difficulty was encountered pushing the pipeline flex device out from within the phenom 27 catheter during analysis.It is likely the damage to the pusher (shrink tubing pulled back, tip coil bent/stretched) and the braid (fraying) occurred when the customer attempted to advance the pipeline flex through the phenom 27 catheter against resistance.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies.In addition, resistance can occur due to patient vessel tortuosity or failure to maintain a continuous flush.The vessel anatomy was normal in tortuosity and a continuous flush was maintained.It is possible the damage found with the phenom 27 distal tip contributed to the event; however, the cause for the damage and the cause for the resistance could not be determined.Regarding the customer¿s ¿failure/incomplete open distal¿ report, the issue could not be confirmed.It is likely the damage (fraying) found with the pipeline flex braid contributed to the event.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 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12442755
• MDR Text Key: 271648353
• Report Number: 2029214-2021-01135
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000283957
• UDI-Public: 00763000283957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: PED2-300-10
• Device Catalogue Number: PED2-300-10
• Device Lot Number: B204667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 71 KG