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

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

Patient Problems Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Vasoconstriction (2126); Stenosis (2263); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The pipeline devices have not been returned for evaluation; product analysis cannot be performed.The devices have not been returned; the reported events could not be confirmed.The causes of the events could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Harland ta, seinfeld j, white ac, kumpe da, roark cd, case de.Comparative analysis of unruptured cerebral aneurysm treatment outcomes and complications with the classic versus flex pipeline embolization devices and phenom versus marksman microcatheter delivery system: the role of microcatheter choice on complication rate.J vasc interv neurol.2020;11(1):13¿18.Medtronic literature review found reports of patient complications after pipeline implantation.The purpose of this article was to evaluate the outcomes of aneurysms treatment with pipeline flex vs.Pipeline classic.The authors reviewed the results of 75 pipeline (ped) procedures: 35 ped classic and 40 ped flex.The following outcomes were noted: of the ped flex cohort: - 1 thrombosis - 1 dissection - 13 vasospasm - 6 intimal hyperplasia - 2 subarachnoid hemorrhage - 1 intraparenchymal hemorrhage.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9930396
• MDR Text Key: 195547694
• Report Number: 2029214-2020-00340
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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: 03/10/2020
• 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): Other