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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

The pipeline devices have not been returned for evaluation; product analysis cannot be performed.The devices have not been returned; the reported events could not be confirmed.The causes of the events could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Gomez-paz, s., akamatsu, y., moore, j., ogilvy, c., thomas, a., & griessenauer, c.(2020).Implications of the collar sign in incompletely occluded aneurysms after pipeline embolization device implantation: a follow-up study.American journal of neuroradiology, 41(3), 482¿485.Doi: 10.3174/ajnr.A6415.Medtronic literature review found a report of retreatment after pipeline implantation.The purpose of this article was to report the angiographic outcomes of patients with collar sign angiographic images and the implications of the finding.The authors retrospectively reviewed the results of 198 patients and identified 17 patients who showed a collar sign on the first angiographic follow-up.The article states that 10 of the patients underwent retreatment in which a second pipeline device was placed.

• 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 ; 9496801345
• MDR Report Key: 9927318
• MDR Text Key: 195547980
• Report Number: 2029214-2020-00336
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• 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