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

Model Number NV UNK PIPELINE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Infarction, Cerebral (1771); Hemorrhage/Bleeding (1888); Muscle Weakness (1967)

Event Date 03/01/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a literature article related to the use of pipeline in off label use.The authors reviewed thirty six patients who were treated with the pipeline for an off label use.The average age of patients was 58 years old, 53% female, with 81% of the aneurysms involved being unruptured.The study took place between march 2015 and december 2017.The article states that there were postoperative complications including 7 postoperative aneurysm ruptured, 4 ischemic strokes and one groin hematoma.None led to significant disability at follow-up, and there was no patient mortality.One patient experienced left-sided weakness following pipeline placement, with an mri showing a right mca infarct.The patient's weakness improved with them being discharged from baseline at 3 months follow-up.One patient developed right-sided weakness following the procedure, and at follow-up, the patient had very mild right leg weakness.One patient presented with multiple brainstem infarcts and was found to have a giant thrombosed basilar artery aneurysm and expired during their hospital stay.Following pipleine placement the patient was put on comfort care due to the aneurysms and not the pipeline device or procedure.One patient had sudden onset right face and arm numbness 1 day following pipeline placement.They were found to have left p1 occlusion and underwent mechanical thrombectomy.The patient was discharged home with no focal neurologic deficit.

• Brand Name: PIPELINE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9833241
• MDR Text Key: 190147510
• Report Number: 2029214-2020-00229
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/15/2020
• 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): Other
• Patient Age: 58 YR