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

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

Zammar, s., buell, t., chen, c., crowley, r., ding, d., griessenauer, c.,.Simon, s.(2018).Outcomes after off-label use of the pipeline embolization device for intracranial aneurysms: a multicenter cohort study.World neurosurgery.Doi:10.1016/j.Wneu.2018.04.012 the pipeline device 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.Mdrs related to this article: 2029214-2018-00428 2029214-2018-00429, 2029214-2018-00430.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found a report that post-procedure, pipeline migration was observed in one case.The article did not note any patient complications in association with this event.The purpose of this article was to examine the outcomes of the pipeline embolization device (ped) when used for 'off-label' indications.The authors identified 109 patients who underwent 'off-label' ped placement; reasons for off-label use were aneurysm size, location, or both.Of the 109 patients, 83.5% were female and 16.5% were male; the mean age was 54.4 years.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7519830
• MDR Text Key: 108493341
• Report Number: 2029214-2018-00430
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• 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