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

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

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Kang, h., zhou, y., luo, b.Et al.Pipeline embolization device for intracranial aneurysms in a large chinese cohort: complication risk factor analysis.Neurotherapeutics (2021).Doi.Org/10.1007/s13311-020-00990-8 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 [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.Refer to manufacturer report 2029214-2021-00825 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Kang, h., zhou, y., luo, b.Et al.Pipeline embolization device for intracranial aneurysms in a large chinese cohort: complication risk factor analysis.Neurotherapeutics (2021).Doi.Org/10.1007/s13311-020-00990-8 medtronic literature review found reported of patient complications in association with implantation of the classic or flex pipeline embolization device (ped) deployed through a marksman microcatheter.The purpose of this article was to assess real-world predictors of complications and functional outcomes in patients treated with the ped in a chinese population.The authors reviewed 1171 cases of patients treated for intracranial aneurysms using the ped.Of the 1171 patients, the average age was 53.9 years, 813 were female.The following intra- or post-procedural outcomes were noted: major ischemic stroke (51 patients), delayed aneurysm rupture (dar) (24 patients), distal intraparenchymal hemorrhage (diph) (23 patients).

• 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: 12126010
• MDR Text Key: 261690496
• Report Number: 2029214-2021-00826
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• 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: 54 YR