MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-475-18

Device Problems Activation Failure (3270); Migration (4003)

Patient Problem Paresis (1998)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the patient was seen 3 months post procedure showing left side hemiparesis with both upper and lower having 4/5 power.A dsa performed showed 90% stenosis proximally with stent migration and distal stent narrowing.As a result the proximal stenosis was angioplastied with a 3 mm sterling balloon with a good result seen and the patient's symptoms resolving.In (b)(6) 2018 the patient returned again with left side hemiparesis and a facial droop.A dsa was again performed which showed the pipeline had lengthened but improved from the angioplasty in (b)(6).The proximal stenosis had a durable result from the prior angioplasty but the distal end remained narrowed.No intervention was performed at that time and the patient's symptoms resolved.The cause of the migration was unknown the patient underwent pipeline placement surgery in (b)(6) 2018 for treatment of an unruptured, saccular supraclinoid ica aneurysm with a ma diameter of 7 mm and neck diameter of 4 mm.It was noted that the vessel tortuosity was normal.There were no issues during the initial procedure with the pipeline deployed easily in the correct location and stasis seen in the aneurysm post deployment.Full wall apposition was achieved and no side branches were covered by the pipeline.The devices were prepared/flushed as indicated per the ifu.Dual antiplatelet treatment was administered with a pru level of 73 and an inhibition of 65%.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7819994
• MDR Text Key: 118344219
• Report Number: 2029214-2018-00748
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2020
• Device Model Number: PED2-475-18
• Device Catalogue Number: PED2-475-18
• Device Lot Number: A396899
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2018
• Date Device Manufactured: 01/06/2017
• 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: 41 YR