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); Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Kunal vakharia, muhammad waqas, stephan a.Munich, jaims lim, andrew gong, felix chin, kenneth v.Snyder, adnan h.Siddiqui, elad i.Levy.Is contrast stasis after pipeline embolization device deployment associated with higher aneurysm occlusion rates?.Doi:10.1136/ neurintsurg-2019-015610.Medtronic literature review found a report of complications after the use of pipeline.The purpose of the article was to assess the association of degree of contrast stasis in intracranial aneurysms (ias) immediately after pipeline embolization device (ped) deployment with 6- and 12-month angiographic occlusion rates.The study included 119 patients in whom 182 peds were deployed to treat 141 aneurysms.The mean age of the patients was 56.2 +/-13.9 years.- 4 patients experienced thromboembolic complications where 1 patient had a transient ischemic attack and 3 patients had a stroke.- 4 patients experienced hemorrhagic complications.2 patents had symptomatic hemorrhages and 2 patients had asymptomatic hemorrhages.The location of the hemorrhages were 1 in the right anterior frontal lobe, 1 in the right suprasellar cistern, and 2 in the sylvian fissure.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9884514
• MDR Text Key: 195545814
• Report Number: 2029214-2020-00302
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• 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: NOT-RPT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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