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

Model Number PED3-027-600-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report of a pipeline not being deployed well.The patient presented with an ischemin stroke.The healthcare provider had created the dissection and required pipeline vantage due to shield technology and larger diameter stent.They deployed both 6x30 and 6x40 very quickly with unsheathe and some load/unload technique.A quick angiographic check was conducted and the procedure was completed.Two days later, patient was unwell, had another ais.Stents had occluded and distal emboli in m1 region.A second healthcare provider had to aspirate through the stents and distal emboli.They thought it would "clean up" and create an open passage.Angiographically looked much better.The patient was still unwell but there was an improvement.The second healthcare provider thought that the original procedure was rushed and not the fault of the stents.No product issue was identified.The stents were not well opposed to the wall of the vessel.The stents occluded and created a stroke.A physician had to aspirate and mechanic thrombectomy was performed for distal emboli.It was believed that the patient dapt wasn't administered properly.The healthcare provider was satisfied with deployment of stent.However, it was reviewed a couple days later and the angiographic result shows that the stent wasn't deployed well and seemed rushed.The unruptured aneurysm was in the carotid dissection with a false lumen morphology.The vessel tortuosity was normal.The pipeline and any accessory devices were prepared as indicated in the 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.

Event Description

Additional information was received indicating the vantage implants had occluded and the patient was not doing well.Although the anatomical location was on-label, the patient was not administered dapt and rather only mono-platelet therapy.

• 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: 12697619
• MDR Text Key: 282637159
• Report Number: 2029214-2021-01334
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED3-027-600-40
• Device Catalogue Number: PED3-027-600-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• 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): Required Intervention
• Patient Sex: Male