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

Model Number PED-425-20

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 12/24/2021

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 ped pipeline failed to open at the distal tip and was damaged.The patient was being treated for an unruptured saccular aneurysm in the right internal carotid artery ophthalmic artery segment.The max diameter was 6.2mm.The neck diameter was 5.6mm.The distal landing zone was 4.1mm and the proximal landing zone was 4.2mm.Vessel tortuosity was normal.The devices were prepared according to the instructions for use (ifu).Dual antiplatelet treatment was administered.Angiographic result post procedure was normal.Attempted to open the ped at the tip end in the middle cerebral aneurysm, but it could not be opened.Pull back to the internal carotid artery and the tip end was opened, but found that the tip of the stent was damaged, so replaced with another stent and deployed it.The pipeline was not positioned in a bend.Less than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.No additional steps were required to open the pipeline.The pipeline was removed directly from the patient.No symptoms were reported.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex pusher and marksman micro catheter were returned for analysis within a shipping box and within a sealed plastic biohazard pouch.Visual inspection/damage location details: no damages were found with the proximal pusher.The hypotube was found unstretched and undamaged with the ptfe shrink tubing still intact.No damages were found with the distal marker, re-sheathing marker, resheathing pad or with the proximal bumper.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The tip coil was found intact and unstretched.The pipeline flex braid was not returned for analysis.Testing/analysis: the marksman micro catheter total and usable length could not be measured as the entire catheter was not returned for analysis.An in-house mandrel was inserted into the micro catheter hub, through the catheter body and out the cut end with no resistance encountered and the braid was not found within the micro catheter.Conclusion: based on the analysis findings, the customer report of ¿failure/incomplete open distal (flex)¿ could not be confirmed as the braid was not returned for analysis.Possible causes are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid was overstretched during delivery, user deploys braid in vessel braid, presence of other indwelling stents or inappropriate anatomy.Customer report of ¿pipeline damaged during delivery/retrieval¿ could not be confirmed.Possible causes are resheathing more than 2 times, high force delivery, over-manipulation, delivering/retracting delivery wire against resistance, or deploying/resheathing braid against resistance.Customer reported patient vessel tortuosity as normal, devices were prepared and flushed per ifu, device resheathed less than or equal to 2 times, and device not placed in a vessel bend.No damages were found with the micro catheter that would contribute towards the failures.Customer did not give a reason for the catheter to be returned cut.There is no ind ication that the event is related to a potential manufacturing issue.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: 13113023
• MDR Text Key: 284863251
• Report Number: 2029214-2021-01680
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-425-20
• Device Catalogue Number: PED-425-20
• Device Lot Number: B252745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• 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: 38 YR
• Patient Sex: Female