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

Model Number PED2-475-18

Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Medtronic received information that a ped2 pipeline had resistance and failed to open in the middle section.There was movement during deployment.The patient was being treated for an unruptured, saccular aneurysm in the right internal carotid artery (ica).The max diameter was 13mm and the neck diameter was 4mm.The distal landing zone was 4.5mm and the proximal landing zone was 4.8mm.Vessel tortuosity was normal.Dual antiplatelet therapy was administered.The devices were prepared as indicated in the instructions for use (ifu).  during the implantation the healthcare provider (hcp) felt strong resistance in the microcatheter (mc), while opening the pipeline it occurred that in the middle part it's not opening, looks like was stuck.Hcp resheathed pipeline and started to unsheath one more time, than it occurred, it's very loose, no tension felt in hand.Hcp decided to go back with mc and pipeline, after taking it out from the patient it looked that pipeline is broken from navigation part and it looks like glued.The pipeline was not positioned in a bend.Less than 50% had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.No additional steps were taken to open the pipeline.The pipeline was removed from the patient with the mc.There was movement during placement (difficult placement/positioning).Multiple pipelines were not used.There was severe friction or difficulty during delivery or positioning.The device was implanted at the intended location.It did not miss the landing zone or jump during deployment.It was placed at least 3mm past the aneurysm neck on each side.No side branches were covered by the pipeline.The catheter tip moved during deployment.Angiographic results post procedure were without harm.No symptoms were reported.   ancillary devices: excelsior xt-27 (xt275081) microcatheter, portal (phenox) guidewire.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex /w shield device and excelsior xt-27 micro catheter were returned for analysis within shipping box; and within two sealed biohazard pouches.Visual inspection/damage location details: no damages or irregularities were found with the xt-27 micro catheter hub.The micro catheter body was found broken at the hub junction with the inner coil exposed and broken as well.The xt-27 micro catheter tip and marker band were found undamaged.The pipeline flex w/ shield pusher was found kinked at ~61.2cm from the proximal end.The pipeline flex w/ shield tip coil was found stretched.The ptfe dps sleeves were found undamaged.The pipeline flex hypotube was found stretched and broken with the ptfe shrink tubing still intact.The braid was found still on the distal segment of the pusher.The braid was found not fully opened throughout the length of the braid.The braid was found entangled with the xt-27 inner coil.Both braid ends were found damaged and frayed.Testing/analysis: resistance testing could not be performed due to the damages.The inner coil was removed, and the middle braid fully opened.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open at middle section (hourglass shape¿ was confirmed.The cause of the failure is due to the entanglement found with the inner coil from the broken micro catheter as the middle braid fully opened when the inner coil was removed.It is likely the micro catheter broke due to advancing the device against the reported resistance.Customer report of ¿movement during deployment¿ typically could not be confirmed through device analysis and no images or videos were submitted for review.Possible causes of movement during deployment are vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, insufficient distal anchoring of braid, or incorrect braid sizing.Customer report of ¿resistance/stuck during delivery¿ was confirmed as the damages found are consistent with advancing/retracting the device against resistance.The hypotube was found stretched and broken, the tip coil was found stretched, and the micro catheter was found broken, indicative of resistance.Possible causes for resistance are damaged catheter, damage to ped or pushwire, frayed ends on braid, patient vessel tortuosity, user does not maintain continuous flush, user pulls back on/torques wire while advancing ped in micro catheter.Customer reported vessel tortuosity as normal, devices were prepared per ifu, device was not positioned in a bend and pipeline was resheathed less than or equal to 2 times.The broken hypotube end was sent out for sem analysis.The sem report concluded that ¿the ribbon failed via shear ductile overload¿ this issue has been investigated before and an additional investigation is not required.Possible contributors towards failure are patient vessel tortuosity, resistance during delivery/retrieval, over-manipulation, catheter damage or user re-sheaths more than two times.There was no non-conformance to specifications identified that led to the reported issues.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.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.

Manufacturer Narrative

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

Additional information received reported that during the procedure, there was resistance with the pipeline at the catheter hub.

• 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: 14095915
• MDR Text Key: 298725764
• Report Number: 2029214-2022-00624
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2022

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: 03/05/2024
• Device Model Number: PED2-475-18
• Device Catalogue Number: PED2-475-18
• Device Lot Number: B171750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/13/2022; 05/28/2022
• Supplement Dates FDA Received: 04/25/2022; 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2021
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 80 KG