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

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 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
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/03/2021
• 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): Required Intervention
• Patient Age: 75 YR