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

Model Number NV UNK PIPELINE

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

Patient Problems Headache (1880); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Embolism/Embolus (4438)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Kühn al, satti sr, eden t, et al. Anatomic snuffbox (distal radial artery) and radial artery access for treatment of intracranial aneurysms with fda-approved flow diverters. Ajnr american journal of neuroradiology. 2021;42(3):487-492. Doi:10. 3174/ajnr. A6953. If information is provided in the future, a supplemental report will be issued.

Event Description

Kühn al, satti sr, eden t, et al. Anatomic snuffbox (distal radial artery) and radial artery access for treatment of intracranial aneurysms with fda-approved flow diverters. Ajnr american journal of neuroradiology. 2021;42(3):487-492. Doi:10. 3174/ajnr. A6953 medtronic literature review found a report of patient complications in association with a pipeline embolization device and phenom plus/phenom 27 catheters. The purpose of this article was to present experience with transradial (distal radial/anatomic snuffbox and radial artery) access as an alternative to femoral artery access for treatment of intracranial aneurysms using all 3 fda-approved flow diverters. Seventy-four patients (64 female) were included in the article, with a mean age of 57. 5 years. A pipeline device was used in 65 of the 74 procedures. The following intra- or post-procedural outcomes were noted: - 3 cases (4. 1%) required conversion to femoral access due to tortuous anatomy and limited support of the catheters in 2 cases and an inability to navigate the catheters to the target vessel in a patient with an aberrant right subclavian artery. - 2 patients showed a smallamount of subarachnoid hemorrhage (sah) on postprocedural head ct. One of these patients had mild headache but was neurologically intact. The other patient showed new right-arm weakness on awakening from anesthesia and was brought back to the angiography suite where hyperacute platelet aggregation within the stent was identified and successfully treated with intra-arterial eptifibatide. The patient fully recovered within 6 months with an mrs of 0. In one patient acute clot formation was encountered during placement of the flow diverter, which was immediately treated with intra-arterial eptifibatide. Asymptomatic radial artery occlusion was encountered in 1 case (3. 7%). The initial procedure in this patient was performed via the radial artery (volar access) with a spasmolytic cocktail consisting of 2. 5mg of verapamil and nitroglycerin, 100mcg. Follow-up angiography in this patient was performed via the ulnar artery.

• Brand Name: PIPELINE
• 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: 12424691
• MDR Text Key: 271467946
• Report Number: 2029214-2021-01110
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/03/2021 Patient Sequence Number: 1