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

Model Number PED2-500-20

Device Problem Activation Failure (3270)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information reporting that 2 pipeline flex with shield devices failed to open in the middle section.A third pipeline flex with shield was successfully deployed but the patient experienced vessel occlusion immediately after implantation.The devices were prepared according to the instructions for use (ifu).The first pipeline flex with shield (model: ped2-500-20) was positioned and started to open the distal part on m1.However, the portion covered by the fins opened partially, and the proximal portion soon after did not open, and the remainder of the flow diverter until close to the repositioning mark opened normally.Recapping maneuvers were performed, dragging to the aci, but none of the maneuvers changed the flow diverter's non-opening.Thus, the entire system was removed and a new pipeline flex with shield (ped2-500-18) was prepared as indicated by ifu.It was positioned and started to open the distal part on m1.However, as the same of the last one, the portion covered by the fins opened partially, and the proximal portion soon after did not open, and the remainder of the flow diverter until close to the repositioning mark opened normally.Recapping maneuvers were performed, dragging to the aci, but none of the maneuvers changed the pipeline non-opening.Thus, the entire system was removed.It was noted the failed pipelines were not positioned in a vessel bend.The pipeline was more than 50% deployed when the failure to open was observed.The pipelines were resheathed 2 or less times.No other steps or devices were tried to open the pipelines.A new pipeline flex with shield (ped2-450-18) was prepared as indicated by ifu.This time it was positioned and deployed effectively.However, moments after implantation, the patient had an arterial occlusion.The physician had to perform an aspiration to restore blood flow.The patient was in serious condition, and remained so at time of the report.The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of the left internal carotid artery (ica).The aneurysm max diameter was 5mm and the neck diameter was 4mm.Dual antiplatelet treatment (dapt) was administered but pru level was unknown.Vessel tortuosity was moderate.

Manufacturer Narrative

Product analysis: as found condition: the pipeline flex shield embolization device and marksman catheter were returned for analysis within shipping box; within an opened pipeline flex with shield and marksman outer cartons and inner pouches.The pipeline flex with shield pushwire was returned partially outside the marksman catheter.In addition, tip coil and sleeves were deployed from marksman distal tip.Visual inspection/damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex shield were found fully opened and moderately frayed.In addition, the middle section of the braid was also found fully opened and no damage.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.Testing/analysis: the pipeline flex shield was pushed out from marksman catheter without any issues.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues.Conclusion.Based on the analysis findings, the pipeline flex shield was not confirmed to have failure to open at the middle section.The event cause could not be determined as the middle section of the braid appeared fully opened with no damage.In addition, the distal and proximal ends of the braid appeared fully opened and moderately frayed.However, the cause for damage could not be determined.It¿s possible that the patient tortuous anatomy may have contributed to the failure to open issue.There was no non-conformance to specification that may have contributed to the failure to open 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 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: 12722128
• MDR Text Key: 279237025
• Report Number: 2029214-2021-01359
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B189518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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 Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG