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

Model Number PED-350-18

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

Patient Problem Vasoconstriction (2126)

Event Date 01/13/2021

Event Type  Death  

Manufacturer Narrative

Patient age ((b)(6) years) is representative of the mean age of all patients included in the study.Patient sex (female) is representative of the majority of all patient included in the study.If information is provided in the future, a supplemental report will be issued.

Event Description

Zhang, p., zhong, w., li, t., tan, x., chen, c., li, m., li, z., li, g., <(>&<)> wang, y.(2021).Flow diverter-assisted coil embolization of blood blister-like aneurysm using semi-deploying technique.Frontiers in neurology, 11, 625203.Https://doi.Org/10.3389/fneur.2020.625203.Abstract despite many therapeutic methods were utilized to treat blood blister-like aneurysms (bbas), the optimal treatment approach has not yet been defined.This study presents the single center experience with bbas treated with flow diverter-assisted coiling using semi-deploying technique, and discusses the efficacy and safety of the method.The patients with subarachnoid hemorrhages (sah) due to bbas and treated with pipeline flex embolization device (ped) between november 2015 and february 2019 in our hospital were retrospectively reviewed.Patient demographic data, timing of treatment, angiographic details, treatment techniques, clinical outcomes and follow-up results were recorded.Ten cases (6 women and 4 men) were enrolled.The mean age of patients was 50.7 years (range 40¿61 years).The aneurysm size ranged from 2 × 1.7mm to 4.5 × 3.8mm.Seven patients were treated with ped assisted coil embolization using semi-deploying technique, and all of the aneurysms were totally obliterated at the follow up.Three patients were treated with ped only, only one of which had incomplete obliteration of the aneurysm during the follow up period.One patient treated with ped assisted coil embolization suffered from parenchymal hemorrhage 3 days after the treatment,and another one patient also treated with ped and coil died of severe vasospasm 10 days after the treatment.There was no reruptured cases during the follow-up.Here we showed that ped assisted coil embolization using semi-deploying technique could be a technically safe and effective treatment for bbas.Medtronic review of the literature article found that it was noted all procedures were considered successful post-operatively.No device malfunctions or intra-procedural issues were described.Patient 8 was treated with a pipeline 3.5 x 18.The patient developed severe vasospasm on the first day after the treatment, and died 10 days later in spite of symptomatic treatment.

• Brand Name: PIPELINE FLEX
• 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: 13448077
• MDR Text Key: 285033813
• Report Number: 2029214-2022-00157
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-350-18
• Device Catalogue Number: PED-350-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• 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; Death
• Patient Age: 50 YR
• Patient Sex: Female