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

Model Number PED3-021-300-12

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that a patient experienced intracranial hemorrhage during a pipeline procedure.It was noted that there had been catheter kick back and moderate resistance during delivery/positioning.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the basilar artery.The max diameter was 14mm, and the neck diameter was 4mm.The patient's vessel tortuosity was minimal.The landing zone was 2mm distal and 2.75mm proximal. dual antiplatelet treatment had been administered.It was reported that they were trying to coil the aneurysm using the jailing technique, which involves two microcatheters side by side - one for delivering coils and another for the pipeline. there were many maneuvers involved since this patient had proven to be difficult, and they were constantly losing the position of both catheters and trying to reposition them. when doing a routine run, it was noticed that a bleed in the place it was believed the tip coil of the pipeline was, so the initial deduction if that the tip coil went to one of the smaller side branches and ruptured the vessel.However, it was unsure where the bleed originated.The pipeline did not jump during deployment, and only a single pipeline was being used.The tip of the catheter was not under stress, and the tip of the catheter moved during deployment. angiographic results post procedure showed a brain bleed.It was noted that the patient later underwent a craniotomy.The devices were prepared according to the instructions for use (ifu).

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 patient was still in the hospital recovering from the procedure.It was indicated there was no resistance in the catheter.There was no damage to the pipeline pushwire or catheter observed.A phenom 21 was used.

Manufacturer Narrative

H3.Product analysis:¿ equipment used: vis (m-81805), 203cm ruler (m-83360) ¿ as found condition: the pipeline vantage embolization device was returned within a shipping box, within a primary sealed pouch, and within a secondary sealed pouch.¿ visual inspection/damage location details: no bends or kinks were found with the pipeline vantage pusher.The pusher arm¿s and sleeves were found in good condition.The pusher tip coil was found bent.The braid was returned already detached from the pusher.The braid ends were found in good condition.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿, ¿catheter kick back¿ and ¿movement during deployment¿ reports could not be confirmed.No defect was found with the returned devices that would have contributed to the event.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the investigation conducted resistance can occur during tracking, deployment, and re-sheathing of the device in distal and tortuous anatomies.It is possible the patient¿s anatomy contributed to the event.However, the root cause could not be determined.The phenom 21 catheter used in the event was not returned.Therefore, an analysis could not be performed, and any contributing factors could not be assessed.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: 13386287
• MDR Text Key: 294256432
• Report Number: 2029214-2022-00113
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/12/2022

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 Model Number: PED3-021-300-12
• Device Catalogue Number: PED3-021-300-12
• Device Lot Number: B219034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 02/02/2022; 03/27/2022
• Supplement Dates FDA Received: 02/15/2022; 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Life Threatening
• Patient Sex: Female