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

Model Number PED2-500-25

Device Problems Appropriate Term/Code Not Available (3191); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Medtronic received a report of two pipeline devices having deployment failures.Additional information was received indicating the devices got stuck and failed to open.They were unable to be resheathed/deployed by the physician.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX W/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: 13712808
• MDR Text Key: 286961322
• Report Number: 2029214-2022-00377
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100018
• 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
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: PED2-500-25
• Device Catalogue Number: PED2-500-25
• Device Lot Number: B047535
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2022
• Date Device Manufactured: 06/29/2020
• 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