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

Model Number PED2-500-12

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

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline failed to open distally, experienced resistance in the phenom 27 microcatheter, and the braid was frayed.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left paraophthalmic segment.The max diameter was 8mm, and the neck diameter was 5mm.The patient's vessel tortuosity was severe.The landing zone was 3.7mm distal and 5.1mm proximal.The access vessel was the left ica, which was 5mm in diameter. dual antiplatelet treatment was administered, and the pru level was 120.It was reported that phenom 27 was placed in left m1 artery.Normal prep of pipeline device was performed with rhv backflush.The device was pushed all the way up and unsheathed the tip coil, and they began to push the pipeline device.The distal device was not opening, so physician re-sheathed the device to the ptfe sleeves, and began to push the device again with no opening.The physician then decided to un-sheath more device (50%), and it was delivered with obvious restraint.They began to apply forward load with the phenom 27 to get the braid to open.There was no response, and under magnification of fluoro the tip braid appeared to be frayed.The physician did not feel comfortable using the device, and retrieved device and removed the phenom 27.A different flow diverter was used to successfully treat the aneurysm.The pipeline was not in a bend, and more than 50% of the device had been deployed when it failed to open.The pipeline had been resheathed more than 2 times.There were no additional steps taken to open the device.The patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include an 80cm stryker infinity sheath, phenom plus guide catheter, and scientia aristotle 14 soft 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.

Manufacturer Narrative

H3: product analysis #704901448:equipment used: vis (m-81805), 203cm ruler (m-83361) document used: n/a as found condition (condition of returned device): a pipeline flex embolization device and a phenom-27 catheter were returned for analysis within a shipping box and within a resealable plastic biohazard bag.Visual inspection/damage location details: the inner diameter (id) of the phenom-27 microcatheter was found to be 0.027¿ per ifu (instructions for use).Per pipeline flex embolization device instructions for use (ifu): ¿the pipeline flex embolization device is designed to be delivered through a compatible micro catheter of 0.027¿ inside diameter.Therefore, the phenom-27 micro catheter was found to be compatible for use with the pipeline embolization device.(pli-10) no bends or kinks were found with the pipeline pushwire.The hypotube and ptfe were found to be intact.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves appeared to be in good condition.No damages were found with the tip coil.Due to the condition in which the braid was returned the proximal and distal ends of braid were unable to be determined.Braid end 1 was found to be opened and frayed.Braid end 2 was found to be opened and frayed.No other anomalies were found with the device.(pli-20) no damages were found with the phenom hub.The phenom total length was measured to be ~159.2cm.The useable length was measured to be ~152.6cm.No bends or kinks were found with the catheter body.No damages were found with the distal tip.Testing/analysis (including sem reports): the catheter was flushed; water exited the distal tip.The phenom catheter was tested with an in-house 0.026in mandrel.The in-house mandrel was inserted into the phenom hub and was able to pass through the distal tip without issue.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was unable to be confirmed as both braid ends were found to be opened.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.The customer reported vessel tortuosity as severe and re-sheathing device more than the recommended two times.Based on the device analysis and reported information, the customer¿s report of ¿pipeline damaged during delivery/retrieval¿ was unable to be confirmed and the root cause could not be determined.Possible causes for ¿pipeline damaged during delivery/retrieval¿ include re-sheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, deploying/re-sheathing braid against resistance and use of incompatible device.It is likely re-sheathing the device more than 2 times caused the pipeline damage during delivery/retrieval.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was unable to be confirmed and the root cause could not be determined.In addition, no issue was found during catheter resistance testing with an in-house mandrel.Possible causes for ¿catheter resistance¿ are patient vessel tortuosity, continuous flush rate too low, catheter or delivery system damage or insufficient delivery system hydration.(reyesr32 2022-04-20) 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 there was no damage to push wire or catheter.

• 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: 13967023
• MDR Text Key: 298228156
• Report Number: 2029214-2022-00529
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284688
• UDI-Public: 00763000284688
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-12
• Device Catalogue Number: PED2-500-12
• Device Lot Number: B296215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG