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

Model Number PED2-450-20

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that after positioning the marksman at the desired location, the pipeline was successfully loaded in the microcatheter.However, the stent could not be unsheathed or deployed as the pipeline was stuck inside the distal segment of the catheter.A continuous flush had been administered, and the physician released the load in the system in an attempt to resolve the issue, but was unsuccessful.It was observed the catheter was accordioned proximally from the middle segment.In an effort to deploy the pipeline, the proximal end of the pushwire was kinked due to a hard push.The devices were removed, and there was no injury to the patient as a result of the event.A second surgery had not been performed at the time of the report, but another surgery for implantation of a flow diverter is planned.The patient was undergoing surgery for compaction of previously coils ruptured aneurysm of the distal internal carotid artery (ica) with minimal vessel tortuosity.The recurrent aneurysm was 13x11 mm.Dual antiplatelet therapy (dapt) had been administered: ascard and plavix.It was noted there was increased timing of the procedure and more radiation dose to the patient and team, but no symptoms or patient complications associated with the event.Post-procedural angiographic results showed residual aneurysm with slight flow decrease observed during the procedure.

• 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: 12337845
• MDR Text Key: 267115516
• Report Number: 2029214-2021-01029
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: P100018 S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: PED2-450-20
• Device Catalogue Number: PED2-450-20
• Device Lot Number: B101964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2021
• Date Device Manufactured: 10/14/2020
• 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 Weight: 79