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

Model Number PED2-450-14

Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the distal end of the pipeline stent failed to open, and the ptfe sleeves would not resheath into the phenom 27 microcatheter.The device became locked up at the distal end.The physician pulled as hard as they could, and they still would not retract.After releasing the load in the system and multiple attempts, the distal end finally opened and the sleeves released.Resheathing had been performed less than three times, and the stent was not positioned in a bend.The delivery system was removed with no further issues to complete the procedure.Full wall apposition had been achieved.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a ruptured aneurysm with moderate vessel tortuosity.Ancillary devices include a phenom plus sheath, phenom 27 microcatheter.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12381596
• MDR Text Key: 268723889
• Report Number: 2029214-2021-01082
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284510
• UDI-Public: 00763000284510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018 S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-14
• Device Catalogue Number: PED2-450-14
• Device Lot Number: B207208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2021
• Date Device Manufactured: 05/17/2021
• 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