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

Model Number PED3-027-400-14

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problem Dysphasia (2195)

Event Date 12/08/2021

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 ped3-027-400-12 lot number: b224530 migrated after deployment.Distal part of the stent no longer covered the aneurysm neck.The cause was not enough distal anchoring.Stent appeared to be opposed before it happened.The second ped3-027-400-14 lot number: b219567 was telescoped inside the first stent covering the aneurysm.However after the stent was detached it was noticed that it also slipped back.But the aneurysm neck was still covered.The physican elected to secure the stent by deploying a neuroform atlas stent anchoring the stent position.The patient was being treated for an unruptured saccular aneurysm in the left opthamic artery.The max diameter was 6 mm and the neck diameter was 4 mm.The distal landing zone was 3.5 mm and the proximal landing zone was 3.9 mm.Vessel tortuosity was moderate. patient woke up from procedure with dysphasia.The first stent was deployed at the intended location.Full was apposition was achieved.No side branches covered by pipeline.The d istal part of the second stent was not well anchored despite appearance.The pipeline was not implanted at the intended location.The second pipeline missed the landing zone.No side branches covered by pipeline.Angiographic result post procedure contrast stasis in aneurysm.

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 received reported that there was no friction or difficulty getting the device to the aneurysm neck.The device was in the correct position up until the point of no return/detachment.The pipeline was implanted using the push/pull deployment technique, where forward push was applied to the stent delivery system and at the same time the microcatheter was being withdrawn.The stent migrated due to the lack of distal anchoring.On fluoroscopy the stent appeared well apposed which is why the physician proceeded with detaching the stent, or they would have resheathed and repositioned the device.The first stent was not implanted in the intended located, and the second stent was in a suboptimal location thus requiring a neuroform atlas stent to stabilize the construct.

• 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: 12989826
• MDR Text Key: 289194966
• Report Number: 2029214-2021-01601
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED3-027-400-14
• Device Catalogue Number: PED3-027-400-14
• Device Lot Number: B219567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2021
• Date Device Manufactured: 06/11/2021
• 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