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

Model Number PED-375-35

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

Patient Problems Headache (1880); Visual Disturbances (2140)

Event Date 03/13/2016

Event Type  Injury  

Manufacturer Narrative

Since 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.No corrective action.Monitoring and trending this type of event.Please refer to mdr#s for the other two devices.2029214-2020-00653 2029214-2020-00654.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that patient experienced adverse event of mass effect deterioration (main symptom), headache, and eye movement disorder a few days after patient had three medtronic flow diverters implanted.There were no issues with the pipelines.The first flow diverter (ped-375-35) was implanted.The second flow diverter (ped-475-35) was implanted to overlap the first one and the third flow diverter (ped-500-35) was implanted to overlap the second.The severity of the adverse event was not serious, and the patient was confirmed to have recovered approximately 1 year later.There was causal relationship with the equipment and procedure as it could not be denied.Prior to the event, it was reported the target aneurysm was discovered incidentally while treating headache and cranial neuropathy.The patient was undergoing embolization treatment of a saccular aneurysm measuring 35mm diameter and neck (unknown dimensions) located in the cavernous sinus segment of the right internal carotid artery (ica).The patient was on dual antiplatelet therapy regimen of aspirin and clopidogrel administration.The patient did not have any optic nerve symptoms but did have mass effect (iii-iv disorder).The mrs (modified rankin scale) rated was 1: although there were symptoms, no obvious disability: it is no problem to perform daily work and activities.Post procedure during the 7-month follow up, the mass effect (iii-vi disorder) deteriorated.The corrected mrs rating was 2.For the 1 month and 2-year follow up, there was no treatment.For the 1-year follow up, it was observed that the mass effect (iii-vi disorder) was still there but improved.The corrected ranking scale was 1.For 3-years follow up after the treatment, the mass effect (iii-vi disorder) was still there but no change.Corrected rankin scale rating was 1.

• 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: 10228607
• MDR Text Key: 201258587
• Report Number: 2029214-2020-00652
• Device Sequence Number: 1
• Product Code: OUT
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2020

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: Health Professional
• Device Expiration Date: 03/27/2018
• Device Model Number: PED-375-35
• Device Lot Number: A080840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/03/2020
• 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): Disability
• Patient Age: 31 YR
• Patient Weight: 55