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

Model Number NV UNK PIPELINE

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Stenosis (2263)

Event Date 10/26/2019

Event Type  Injury  

Manufacturer Narrative

See related regulatory reports 2029214-2020-01290 and 2029214-2020-01291.If information is provided in the future, a supplemental report will be issued.

Event Description

Cherian, jacob, mahsa dabagh, visish m srinivasan, stephen chen, jeremiah johnson, ajay wakhloo, vipul gupta, j macho, amanda randles, and peter kan.2020.¿balloon-mounted stents for treatment of refractory flow diverting device wall malapposition.¿  operative neurosurgery (hagerstown, md.) 19 (1): 37¿42.Doi:10.1093/ons/opz297.Medtronic received a literature article aiming to describe the use of balloon-mounted stents within flow diverters for correction of flow-limiting stenosis and device malapposition.After attempts to perform balloon angioplasty proved unsuccessful, bms deployment successfully opened the stenotic parent artery and improved fdd wall apposition in all 4 cases.In the third case a 57-yr-old woman was found incidentally to have a giant left cavernous ica aneurysm.A site of pre-existing stenosis was noted immediately proximal to the aneurysmal segment.A compliant balloon was used to angioplasty the site of stenosis resulting in mildly improved vessel caliber.A pipeline device was then deployed to span the petrous and cavernous ica segments inclusive of the fusiform aneurysm.Unfortunately, post-deployment angiography revealed critical fdd stenosis at the site of pre-existing stenosis.Angioplasty with a non-compliant coronary balloon was not durable.A bms was then deployed at the site of stenosis with successful opening of the fdd and parent vessel.Post-angiography demonstrated mild residual narrowing.The patient¿s post-procedure course was complicated by seizures and concerns for hyper-perfusion syndrome.These symptoms were managed with steroids, hyperosmolar therapy, and blood pressure control.The patient ultimately improved clinically and was successfully discharged on the fourth postoperative day.The patient was asymptomatic at 6 month and follow-up angiogram showed complete aneurysm obliteration with no residual stenosis.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10999346
• MDR Text Key: 221464337
• Report Number: 2029214-2020-01292
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2020
• 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): Required Intervention
• Patient Age: 28 YR