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 Stroke/CVA (1770); Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440)

Event Date 04/20/2021

Event Type  Injury  

Event Description

Jee t, yeon j, kim k, kim j, hong s, jeon p.Early clinical experience of using the surpass evolve flow diverter in the treatment of intracranial aneurysms.Neuroradiology.(2021) 64:343¿351.10.1007/s00234-021-02793-w.The purpose of this article was to presented the early experience with flow diversion procedures using the surpass evolve flow diverter (se, stryker) and reported the feasibility and safety profile compared to those of a control group treated with other types of flow diverters.Included were 31 and 53 consecutive flow diversion procedures performed using the se and other commercial flow diverters, respectively, to treat intracranial aneurysms at our institution.We used two commercial flow diversion systems in the comparison group: the pipeline embolization device and surpass streamline.In the se group, technical failures occurred in three (9.7%) cases, due to either incomplete wall apposition or stent migration (n=2, 6.5%).Major complications occurred in four (12.9%) cases: delayed rupture of the target aneurysm (n=1, 3.2%), major ischemic stroke (n=1, 3.2%), sudden death from an unidentified cause (n=1, 3.2%), and parent artery occlusion with stent thrombosis (n=1, 3.2%).Balloon angioplasty was performed in eight (25.8%) cases.On post-procedure mri, a dwi-positive lesion was detected in three (9.7%) cases.After multivariate adjustment, the se group was independently associated with less procedural time of=90 min.The following intra- or post-procedural outcomes related to the medtronic pipeline were noted: 1.Hemorrhage, delayed riph 2.Hemorrhage, delayed rupture 3.Major ischemic stroke, embolic 4.Major ischemic stroke, stent thrombosis 5.All stent thromboses.

Manufacturer Narrative

Refer to regulatory rep #: 2029214-2022-00603 for related event information.Jee t, yeon j, kim k, kim j, hong s, jeon p.Early clinical experience of using the surpass evolve flow diverter in the treatment of intracranial aneurysms.Neuroradiology.(2021) 64:343¿351.10.1007/s00234-021-02793-w.Is the age the article was accepted, as no event date was provided.58 years is the average age of the patients who used pipeline devices 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. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14069102
• MDR Text Key: 293340851
• Report Number: 2029214-2022-00604
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• 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
• Date Manufacturer Received: 03/16/2022
• 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): Life Threatening; Other
• Patient Age: 58 YR