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

Model Number PED-375-14

Device Problems Positioning Failure (1158); Unintended Movement (3026)

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

Event Date 10/04/2021

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 pipeline slid off the resheathing pad.The patient was undergoing surgery for flow diversion treatment of a saccular, unruptured aneurysm in the right ophthalmic artery with a max diameter of 5mm and a 4mm neck diameter.The landing zone was 3mm on the distal side and 3.8mm on the proximal side.The access vessel was the right femoral with a diameter of 8mm.It was noted the patient's vessel tortuosity was severe.Dapt (dual antiplatelet treatment) was administered and the pru level was unknown.It was reported that catheters were positioned in vessel appropriately.During deployment of pipeline, the device was positioned too proximal.During resheathing of device, the pipeline slid off the resheathing pad.Most of the device was still captured inside the phenom 27.The cat5 was then advanced over the phenom 27 and pipeline.The phenom 27 and pipeline were then removed from the patient.A second phenom 27 and pipeline were then used.The device was deployed across the aneurysm with good wall opposition.Final angiograms were performed and showed successful device placement as well as aneurysm stasis. the pipeline was not used for an indication that is not approved (off-label).The pipeline and any accessory devices were prepared as indicated in the ifu.Ancillary devices include a stryker infinity sheath, a stryker cat 5 guide catheter, and a syncro 2 guidewire.

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 was received and it was reported that there was fiction or difficulty during delivery and positioning due to tortuosity of ica anatomy.The device did did not jump during deployment.The tip of the phenom 27 only moved during normal deployment maneuvers.(unsheathing, pushing out stent, etc.).

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex device and phenom-27 catheter were returned for analysis within a shipping box and within two various plastic biohazard pouches.The pipeline flex braid was already deployed and returned within the same biohazard pouches.Visual inspection/damage location details: no flash or voids molded were found within the phenom-027 micro catheter hub.No damages or anomalies were found with the hub.The pipeline flex pusher was extending out the hub 43.6cm.The phenom-27 micro catheter was found kinked at 63.0cm from the proximal end.No damages or irregularities were found with the distal tip or marker band.The distal braid and distal wire were found extending out the micro catheter tip.The micro catheter was flushed; and water did not exit the distal end.The pusher was retracted, and the proximal segment of the pusher exited the phenom-27 catheter.The proximal pusher was found separated from the hypotube at 106.5cm (fused joint) with the ptfe shrink tubing damaged at the same location.The distal pusher segment was found stuck the phenom-27 catheter.The catheter was cut to remove the pusher.Dried blood was found within the catheter.The hypotube was intact and unstretched.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.No damages or irregularities were found with the dps restraints and tip coil.The dps sleeves were found damaged.Both braid ends were found damaged and frayed.Testing/analysis: the phenom-27 micro catheter total length was measured to be 157.5cm and the usable length was measured to be 151.0cm, which is within specification (specification: total (ref) = 156.5cm usable = 150cm ± 5cm).The broken distal wire was sent out for sem testing.Conclusion: based on the analysis findings, the customer report of ¿device opens prematurely¿ was confirmed as the braid was found already separated from the resheathing pad.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 time.The customer report of ¿difficult placement/positioning¿ could not be confirmed through device analysis.Possible causes are patient vessel tortuosity, braid incorrectly sized to vessel, resistance, other indwelling endovascular stents, braid damaged, braid deployed in vessel bend, micro catheter tip not correctly placed, or braid not anchored correctly.The braid was found damaged.Potential causes for braid damage are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/resheathing braid against resistance, or damage during return shipping as the braid was returned partly out of the micro catheter tip.There was no non-conformance to specifications identified that led to the reported issues.The pusher was found broken at the proximal core wire and hypotube joint, although the cause could not be determined.The sem results: ¿the part failed at the weld joint area.Dimples indicative of tensile overload are visible on the broken end¿ this is similar to a previous formal investigation.There were no reported separation or resistance issues during the procedure, therefore it is possible the break occurred, post-procedure, during handling or return to medtronic for analysis.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
• 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: 12591549
• MDR Text Key: 275229560
• Report Number: 2029214-2021-01250
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015579
• UDI-Public: 00847536015579
• 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,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: PED-375-14
• Device Catalogue Number: PED-375-14
• Device Lot Number: B059033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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: 63 YR
• Patient Sex: Female