MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK PIPELINE

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

Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); Pseudoaneurysm (2605)

Event Date 11/11/2021

Event Type  Injury  

Event Description

Cohen j, henkes h, gomori j, rajz g, leker r.Standalone flow diversion therapy effectively controls rebleeding of acutely ruptured internal carotid artery trunk (nonbranching) microaneurysms.Journal of clinical medicine.2021, 10, 5249.Https://doi.Org/10.3390/jcm10225249.  the purpose of this article was to review flow diversion treatment as a promising option in selected patients with acutely ruptured microaneurysms.The authors reviewed fifteen cases of patients treated for internal carotid artery (ica) microaneurysms, 13 of which used the ped pipeline stent.Of the 13 patients, the average age was 54 years, 12 were female and 1 was male.  the article does not state any technical issues during use of the pipeline.No procedural complications occurred.Immediately after fds implantation, aneurysms presented different degrees of incomplete angiographic occlusion, with o¿kelly¿marotta scores [12] of a1 in three patients, b1 in four, b2 in one, c2 in six, c3 in one.Despite consistent near-zero or incomplete angiographic exclusion, none of the aneurysms rebled during the hospital stay or follow-up.One patient developed a femoral pseudoaneurysm that was managed with percutaneous injection of thrombin.Two patients complicated with pneumonia.One patient developed symptomatic cerebral vasospasm that was refractory to conservative measures and required endovascular angioplasty.One patient died 27 days after the endovascular intervention and 3 days after transfer to rehabilitation after a suspected fulminant pulmonary embolism.  the following intra- or post-procedural outcomes were noted: 1.One patient developed a femoral pseudoaneurysm 2.Two patients complicated with pneumonia 3.One patient developed symptomatic cerebral vasospasm 4.One patient died after a suspected fulminant pulmonary embolism.

Manufacturer Narrative

Refer to regulatory report# 2029214-2022-00418 for related information.Cohen j, henkes h, gomori j, rajz g, leker r.Standalone flow diversion therapy effectively controls rebleeding of acutely ruptured internal carotid artery trunk (nonbranching) microaneurysms.Journal of clinical medicine.2021, 10, 5249.Https://doi.Org/10.3390/jcm10225249.The information for patient age and gender are averages from the 13 patient's in the study.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13792817
• MDR Text Key: 287803433
• Report Number: 2029214-2022-00419
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2022

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: 03/03/2022
• Initial Date FDA Received: 03/17/2022
• 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: 54 YR
• Patient Sex: Female