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

Model Number PED-450-20

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 03/11/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a patient experienced mass effect after pipeline flex implantation.The patient underwent pipeline flex implantation in the treatment of a cavernous, left internal carotid artery (ica) aneurysm.The aneurysm max.Diameter was 22.4 mm and neck width was 8.9 mm.There were no reports of any device issues during implantation.One day post-intervention, mri image showed worsening mass effect.There was no medical intervention required.The patient is reportedly fine.There was no report of any neurological symptoms as a result of this event.The physician reports the issue was not related to the intervention or to the use of pipeline.The patient reportedly did not have mass effect prior to the procedure.Prior to intervention, the patient¿s mrs was 0.Post-intervention, mrs was 1.There was causal relationship with equipment and the mass effect deterioration.Severity: not serious.Outcome: recovery, outcome confirmation date: march 9, 2017.

• Brand Name: PIPELINE FLEX
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10283907
• MDR Text Key: 207917722
• Report Number: 2029214-2020-00693
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015548
• UDI-Public: 00836462015548
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2020

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: No Information
• Device Expiration Date: 09/02/2018
• Device Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: A156311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2015
• 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: 64 YR