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

Model Number PED2-300-14

Device Problem Break (1069)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not be returned for analysis. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of the second pipeline flex with shield, the adjunctive coiling catheter come out of the aneurysm and it could be repositioned into the aneurysm. However, it again prolapsed into the parent vessel along with the first coil. An attempt was made to recapture the pipeline, but the wire separated from the device. The pipeline separated from the resheathing pad. All devices were removed from the patient. No device was reported to have been implanted in the patient. The procedure was not completed, and the patient was scheduled for retreated on (b)(6) 2019. The patient was undergoing embolization treatment of a ruptured blister aneurysm (unknown dimensions) located in the right internal carotid artery (ica) above the pca. The distal and proximal landing zones were unknown. The patient¿s vasculature was normal in tortuosity.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• 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: 8412960
• MDR Text Key: 138565814
• Report Number: 2029214-2019-00192
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/30/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/03/2020
• Device Model Number: PED2-300-14
• Device Catalogue Number: PED2-300-14
• Device Lot Number: A502829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial