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 Problem Obstruction/Occlusion (2422)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Saal-zapata g, durand w, ghodke bv, walker m.Endovascular strategies for stroke management after subacute in-stent thrombosis. journal of clinical neuroscience.2020;81:18-20.Doi.Org/10.1016/j.Jocn.2020.09.020.Medtronic received a literature article pertaining to patient's with subacute in-stent thrombosis, a rare but potentially fatal condition that can occur after treatment for intracranial aneurysms or stenosis.A male patient with past medical history of migraine presented with subarachnoid hemorrhage resulting from a ruptured left supraclinoid ica blister-type aneurysm.Two telescoping pipeline devices were used as treatment.Eight days post-embolization the patient developed acute right hemiparesis and underwent dsa for evaluation of vasospasm.Instead of vasospasm, non-occlusive intramuralthrombus was found.The patient was placed on heparin drip and returned to the icu, but 12 hours later developed recurrent symptoms.A cta scan revealed an occluded left ica and ct perfusion showed a large ischemic penumbra.As a result mechanical thrombectomy was performed.Upon treatment using thrombectomy the patient recovered fully.

• 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: 11016905
• MDR Text Key: 222004634
• Report Number: 2029214-2020-01308
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• 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: 39 YR