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

Model Number NV UNK PIPELINE

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Paralysis (1997); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

This event was previously reported in manufacturer report # 2029214-2022-00558. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that pipeline patients experienced hemiparesis following the procedure. It was reported that the doctor had previously noticed extravasation of fluid and swelling from the parent treated vessel directly distal to the placement of the pipeline 3-13 hours following implant. In all cases the patients recovered with no neurological deficits. In at least on case he claimed that the patient demonstrated some hemispatial-neglect and hemiparesis. A balloon was not used in the procedures. The doctor stated that diffusion imaging can show contact agent outside the lumen of the vessel. The doctor suspected that a response to the hydrophilic coating may have caused the issue. Other possible causes considered were the duration of the cases, use of too much contrast, and that the use of verapamil in a diseased vessel could induce fluid extravasation in some cases. No conclusive conclusion was determined.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14245251
• MDR Text Key: 291290308
• Report Number: 2029214-2022-00737
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/28/2022 Patient Sequence Number: 1