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

Model Number PED3-027-400-30

Device Problems Unintended Ejection (1234); Detachment of Device or Device Component (2907); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 01/28/2023

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 a report that the proximal section of the pipeline failed to open and the phenom 27 was damaged.The patient was undergoing surgery for treatment of a fusiform, unruptured ica aneurysm with a max diameter of 7mm and a 2.5mm neck diameter.The landing zone was 3.05mm at the distal end and 3.75mm at the proximal end.It was noted the patient's vessel tortuosity was moderate.The access vessel was the ica with 3.75mm diameter.Dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure was the patient was doing well.No patient symptoms or further complications were reported as a result of this event.It was reported that during the procedure the doctor deployed the device distally well and wall opposed but while deploying the device proximal, the proximal part of the device was not opening up.The doctor had to resheath the device twice but proximally the device was not opening up.Finally the doctor had to withdraw the device and in withdrawing the device the device got detached and got stuck in the microcatheter.The microcatheter got damaged when the device got stuck.The proximal section of the catheter was damaged.The pipeline was not positioned in a bend when it failed to open.More than 50% of the pipeline had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.There were no additional step or other devices required to open the pipeline.The pipeline was resheathed and removed from the patient with the microcatheter.The pipeline was used for an indication that is approved (on-label).The pipeline and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.

Event Description

Additional information was received that there was no resistance in the catheter.It was noted that the device got separated.The pushwire was not rotated or pulled back at any time during the procedure.Additional information was received that clarified that the pipeline pushwire was separated; it got separated and was referring to the device detaching and getting stuck in the microcatheter.

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

Product analysis: as found condition: the pipeline vantage shield pusher was returned for analysis within a shipping box; within an opened pipeline vantage shield outer carton and inner pouch; and within a dispenser coil.There was no pipeline vantage shield braid or phenom-27 catheter returned with the pusher.Therefore, any contributing factors could not be assessed.Damage location details: there was no break or separation found with pusher.No bent ok kink was found with pusher.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.No defects were found with the tip coil, distal marker, re-sheathing marker, arms 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.No other anomalies were observed.Testing/analysis: n/a.Conclusion: based on the returned device, the based on the device analysis and reported information, the customer¿s complaints could not be confirmed.No defect was found with the returned pipeline vantage shield that would have contributed to the event.Since the pipeline vantage shield braid and phenom 27 catheter were not returned; any contribution of the braid and catheter to the issues could not be determined.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 VANTAGE WITH 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: 16263726
• MDR Text Key: 308410386
• Report Number: 2029214-2023-00131
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/19/2023

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 Model Number: PED3-027-400-30
• Device Catalogue Number: PED3-027-400-30
• Device Lot Number: B308553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/03/2023; 03/31/2023
• Supplement Dates FDA Received: 02/13/2023; 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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 Sex: Female