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

Model Number PED-500-16

Device Problem Activation Failure (3270)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. The device involved in this event is not approved in the us; the device's brand name and model number are provided below. This report is being filed against a similar device, which is provided in section d. Brand name: pipeline flex with shield technology model number: ped2-500-16 mdrs related to this patient: 2029214-2019-00268, 2029214-2019-00269. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the core labs reported aneurysm (raymond roy class 3) was note in imaging that was performed 4 and 6 months post successful pipeline embolization procedure. It was reported that the first pipeline (ped2-500-15) was re-sheathed to improve wall apposition and the other pipeline (ped2-475-16) was re-sheath to help the distal end open. The patient was undergoing embolization treatment of 2 unruptured saccular aneurysms located in the ophthalmic segment of the right and right internal carotid artery. Post procedural angiography showed significant stasis and complete obliteration of the aneurysm.

• Brand Name: PIPELINE FLEX
• 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 ; 7635263305
• MDR Report Key: 8471939
• Report Number: 2029214-2019-00268
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/19/2018
• Device Model Number: PED-500-16
• Device Lot Number: A175736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 60 YR