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 Ischemia (1942); Muscle Weakness (1967); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: 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.The device was used for an off label indication.If information is provided in the future, a supplemental report will be issued.

Event Description

Matthew b.Potts, michael c.Hurley, sameer a.Ansari, ali shaibani, scott r.Geraghty, thomas j.Grobelny, babak s.Jahromi, mechanical thrombectomy for delayed thrombosis of pipeline embolization device, world neurosurgery, volume 140, 2020, pages 237-240, issn 1878-8750, https://doi.Org/10.1016/j.Wneu.2020.04.202.Medtronic literature review found reported of patient complications in association with implantation of a pipeline embolization device (ped).The authors reviewed one case of a (b)(6), female patient treated for an unruptured fusiform aneurysm using a ped.The procedure was off-label due to the location of the implantation.The article does not state any technical issues during use of the pipeline.Six months post-procedure, occlusion of the aneurysm was confirmed via cerebral angiogram.Eighteen months post-procedure, the patient presented with acute onset of left-side weakness and a national institutes of health stroke scale (nihss) score of 10.At the time of her presentation with an acute ischemic stroke, computed tomography (ct) angiography demonstrated occlusion within the ped construct and ct perfusion showed a large region of ischemic penumbra within the right mca territory.A mechanical thrombectomy was performed, and reperfusion was achieved with a 2a reperfusion score.Two hours later, reocclusion of the ped was demonstrated.Another mechanical thrombectomy was performed and the modified thrombolysis in cerebral infarction (mtici) score was 2a again.The patient was put on dual antiplatelet therapy (dapt) with aspirin 81 mg daily and ticagrelor 90 mg twice daily.The patient remained neurologically intact and remained so at the 1 year follow up.

• 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: 10916666
• MDR Text Key: 218710726
• Report Number: 2029214-2020-01202
• 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: 11/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2020
• 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: 11/13/2020
• 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: 40 YR