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

Model Number PED3-021-350-16

Device Problems Unintended Movement (3026); Migration (4003); Physical Resistance/Sticking (4012)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the first 30% of the pipeline was opened and when a resheathing attempt was made, the tip coil and pusher moved back and the pipeline did not move like the others, so it was disconnected.Resheathing was not possible.The pipeline was not used off label, the pipeline was not used as indicated in the ifu.The pipeline was introduced in the phenom 27, and not the phenom 21 as recommended.There were no patient symptoms or complications associated with the event.A dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure showed good results.Ancillary devices include: phenom 27.

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

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 indicating the aneurysm status was carotido-ophtalmique gauche sacciforme.The patient had normal vessel tortuosity.

Manufacturer Narrative

Product analysis: ¿ equipment used: vis (m-81805), 203cm ruler (m-83360) ¿ as found condition: the pipeline vantage embolization device and phenom 27 catheter were returned for analysis within a shipping box and within sealed pouches.¿ visual inspection/damage location details: the pipeline vantage embolization device was returned within the phenom 27 catheter.The pipeline vantage pusher was found extending out from within the phenom 27 catheter hub for ~45.0cm.The phenom 27 catheter hub was found in good condition.No bends or kinks were found with the catheter body.The catheter distal tip was found in good condition.The pipeline flex braid was found partially deployed out from within the phenom 27 distal tip.The pipeline vantage pusher was pulled out from within the phenom 27 catheter and the braid was pulled out of the catheter distal tip.No bends or kinks were found with the pipeline vantage pusher.The pusher arm¿s were found in good condition.No damage was found with the sleeves; however, the sleeve restraints were found detached (loose) on the distal core wire.In addition, the pipeline vantage tip coil was found detached (loose) from the distal core wire.The pipeline vantage braid proximal end was found in good condition.The braid distal end was found damaged (frayed).¿ conclusion: based on the device analysis and reported information, the customer¿s ¿movement during deployment¿ report could not be confirmed.Possible causes of failure include vasospasm, patient vessel tortuosity, high force delivery, catheter kickback, insufficient distal anchoring of braid, or incorrect braid sizing.However, the cause could not be determined.Regarding the customer¿s ¿resistance during re-sheathing/failure to resheath¿ report the issue was confirmed.Possible causes of failure include patient vessel tortuosity, resistance during delivery/retrieval, ped/delivery system damage, catheter damage, user does not maintain continuous flush, or user resheaths more than 2 time.However, the cause could not be determined.H6.Coding updated based on analysis results.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: 13488172
• MDR Text Key: 294668370
• Report Number: 2029214-2022-00182
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/25/2022

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 Expiration Date: 03/29/2024
• Device Model Number: PED3-021-350-16
• Device Catalogue Number: PED3-021-350-16
• Device Lot Number: B183582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 04/29/2022; 05/24/2022
• Supplement Dates FDA Received: 05/03/2022; 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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: 65 YR
• Patient Sex: Female