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

Model Number NV UNK PIPELINE

Device Problems Break (1069); Positioning Failure (1158); Activation, Positioning or SeparationProblem (2906); Migration (4003)

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

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Fei liang, yupeng zhang, feng guo, yuxiang zhang, peng yan, shikai liang, yuhua jiang, peng jiang, chuhan jiang. (2018). Pipeline embolization device for posterior circulation aneurysms: single-center experiences with comparison with anterior circulation aneurysms, 112. Doi: 10. 1016/j. Wneu. 2018. 01. 129 medtronic literature review found a report of patient complications after pipeline implantation. The purpose of the article was to evaluate the performance of the pipeline embolization device (ped) for posterior circulation aneurysms. The authors retrospectively reviewed the results of 35 patients with 38 posterior circulation aneurysms who underwent treatment with the ped and compared them to 163 anterior circulation aneurysms. The article describes the following posterior circulation aneurysm events: - 1 patient encountered ped foreshortening. The article describes the following anterior circulation aneurysm events: -16 patients encountered malposition. - 3 patients encountered ped migration. - 3 patients encountered ped foreshortening. - 1 patient had the delivery wire fracture during the procedure.

• Brand Name: PIPELINE 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 ; 9496801345
• MDR Report Key: 9167938
• MDR Text Key: 168453320
• Report Number: 2029214-2019-00999
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-REP
• 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: 09/19/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial