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

Model Number PED2-500-14

Device Problem Activation Failure (3270)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the ancillary devices were placed.The pipeline embolization device (ped) (4.75 x 14) was prepped per the instructions for use (ifu), and advanced to the tip of the phenom 27 microcatheter and in the m1 region.The tip coil appeared to be going into the perforator, and the system was drawn back slightly.The ped was pushed forward to reveal the distal part of the braid, and several millimeters were exposed with no opening initially.After a few minutes, the catheter was advanced over the braid again to attempt to push back the polytetrafluoroethylene (ptfe) sleeves.A further attempt to deploy the ped, and the distal tip appeared to be opening, but several millimeters proximally looked to be constricted.The entire system was withdrawn back to check if it had made any difference.The braid was resheathed and another attempt was made with the same results.Since the braid did not look as it should, the system was removed.It was noted the ped was not positioned in a bend, less than 50% had been deployed when it failed to open, and resheathing was performed more than twice.A second ped (5 x 14) was then used but had a similar occurrence.Another replacement device was then used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results were good.The patient was undergoing surgery for treatment of a ruptured blister aneurysm of the left internal carotid artery with a max diameter of 1.5 mm and a 1.5 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.The ped was used for an off-label procedure to treat acute subarachnoid hemorrhage (sah).Dual antiplatelet therapy (dapt) was administered: prasugrel was give two hours prior to the start of the procedure and re-aspirin on deployment.Ancillary devices include a neuron max 80cm, navien 072 115cm, headway duo, phenom 27.Refer to manufacturer report 2029214-2020-01270 for details pertaining to the related reportable event.

Manufacturer Narrative

H3: analysis of the pipeline flex embolization device (model: ped2-500-14 lot: b094547) and phenom 27 catheter (model: fg15150-0615-1s lot: ap19-060) found that the pipeline flex pushwire was bent at ~132.1 cm from proximal end.The hypotube and ptfe were found to be intact.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.Due to the condition the braid was returned the proximal and distal ends of braid were unable to be determined.Both ends of the pipeline flex braid were found to be opened and frayed.The dps sleeves were found intact and not damaged.The tip coil was found to be intact.The phenom-27 catheter total length was measured to be ~158.2 cm.The phenom useable length was measured to be ~149.6 cm which is within specification (specification: 150.0 cm ± 5 cm).Upon visual inspection, no damages were found with the phenom hub.No bends or kinks were found with the catheter body.No damages were found with the distal tip.The phenom catheter was flushed, water exited from the distal tip.The p henom-27 catheter was tested with an in-house 0.026 in mandrel.The in-house mandrel was inserted into the phenom hub and was able to pass through the distal tip without issue.However; based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed with pipeline flex embolization device as the proximal and distal ends of the pipeline flex braid was were found to be collapsed.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.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 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: 10977011
• MDR Text Key: 220501350
• Report Number: 2029214-2020-01271
• 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: 02/25/2021

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: 09/30/2023
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: B094547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR