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

Model Number PED2-425-10

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

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Shaking/Tremors (2515); Thromboembolism (2654)

Event Date 05/05/2021

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 6 days post procedure the patient had tremor, numbness, and slight motor paresis of the left upper extremity.Brain ct scans showed a few hemorrhagic spots in the right hemisphere, and a brain mri showed numerous focal enhancing lesions in the right hemisphere, corresponding to multiple micro-emboli.It was stated that this was probably due to foreign body emboli.Cta/mra/dsa excluded the existence of stent thrombosis.There were no remarkable findings in the cerebral vessels.Patient symptoms were noticed 6 days post procedure.The patient's symptoms were relieved shortly after antiepileptic and corticosteroid medication were administered, with dual antiplatelet therapy also modified.The patient was undergoing treatment of a ruptured, saccular, right p-com aneurysm with a max diameter of 6mm and a neck width of 2mm.It was noted that the patient's vessel tortuosity was normal.The devices were prepared as indicated per the ifu.Dual antiplatelet treatment was administered, with a pru level of 34 seen.Post procedure angiographic results showed excellent stent apposition and residual aneurysm still filling.The initial procedure was without complication and was completed successfully.There was no alleged product issue.A pipeline was used due to residual aneurysm after coiling, but the coil used was unknown.Additional information received reported it was uncertain if the foreign body emboli was related to the pipeline device or accessory device(s).No additional surgical intervention was provided or scheduled.The brain mri that was done post-operatively was considered to be an additional intervention.The plan was to continue normal follow-up and post-operative treatment unless additional symptoms developed.

• 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: 12036606
• MDR Text Key: 265204293
• Report Number: 2029214-2021-00756
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2024
• Device Model Number: PED2-425-10
• Device Catalogue Number: PED2-425-10
• Device Lot Number: B156636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2021
• Date Device Manufactured: 02/04/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 69