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); Hemorrhage/Bleeding (1888); Ischemia (1942); Muscle Weakness (1967); Dysphasia (2195); Neck Pain (2433); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)

Event Date 10/30/2020

Event Type  Injury  

Event Description

Zhou, y., wu, x., tian, z., yang, x., mu, s.(2020).Pipeline embolization device with adjunctive coils for the treatment of unruptured large or giant vertebrobasilar aneurysms: a single-center experience.Frontiers in neurology, 11.Https://doi.Org/10.338 9/fneur.2020.522583.Summary: to evaluate effectiveness and safety of pipeline embolization device (ped) for large or giant verterbrobasilar aneurysms (lgvbas), and to compare the therapeutic effects of ped with and without adjunctive coils.Identified events: in the ped with adjunctive coils group, one patient had a transient ischemic event.One day after the procedure, the patient manifested unilateral limb weakness, speech difficulties, and other manifestations of focal neurological deficits, but these symptoms quickly disappeared, so we considered the cause to be a vasospasm.One patient developed a significant headache and neck pain on the second post-operative day.The cerebral ct showed a small amount of hemorrhage in the lateral fissure pools and cisterna ambiens, indicating the patient had a ruptured aneurysm.After further observation, the patient became asymptomatic and follow-up examinations confirmed complete recovery.One patient developed post-operative acute intracavitary thrombosis and was treated with intraarterial thrombolysis, the patient recovered to mrs 4.One patient suffered stent retraction after the operation; therefore, 2 weeks later, he underwent a second interventional embolization to place another ped and he recovered well.Event information: all cases were unruptured aneurysms.A ped group of nine patients and a ped with adjunctive coils group of 12 patients was analyzed.Fourteen aneurysms were located in the vertebral artery, four in the basilar artery, and three in the junction of the vertebral basilar artery.Of these, 19 were fusiform aneurysms, accounting for more than 90%.Seven patients (33.3%) each presented with two aneurysms, but the other aneurysm was not located in the vertebrobasilar artery or was not large.

Manufacturer Narrative

Zhou, y., wu, x., tian, z., yang, x., mu, s.(2020).Pipeline embolization device with adjunctive coils for the treatment of unruptured large or giant vertebrobasilar aneurysms: a single-center experience.Frontiers in neurology, 11.Https://doi.Org/10.338 9/fneur.2020.522583.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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: 13519408
• MDR Text Key: 289198144
• Report Number: 2029214-2022-00214
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2022
• 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
• 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
• Patient Age: 43 YR
• Patient Sex: Male