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

Model Number PED-350-30

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site. This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
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pipeline flex w/shield technology model# ped2-350-30 the pipeline flex with shield device has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the resistance was experienced when the pipeline flex with shield was advanced into the medtronic catheter. The device was advanced about 50% out of the catheter tip when it was decided to be resheathed and removed the device. During the removal of the device, it was noted to be tearing. The flow diverter was broken in the hub of the catheter while retrieving the system. However, the device was completely removed with the catheter. No patient injury occurred.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 8975587
• MDR Text Key: 180572745
• Report Number: 2029214-2019-00903
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/24/2019
• Device Model Number: PED-350-30
• Device Lot Number: A349422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial