MAUDE Adverse Event Report: COVIDIEN (IRVINE) 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 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.The event could not be confirmed.A cause of the event could not be conclusively determined from the reported information.Wfitn 2015 abstracts: poster display.(2015).Interventional neuroradiology, 21(1 suppl), 66-89.Doi:10.1177/1591019915618081 mdrs related to this article: 2029214-2016-00538 2029214-2016-00539.

Event Description

Medtronic received information from literature review of pipeline migration.The purpose of this article was to review the clinical experience of the pipeline embolization device.Records of 16 patients (mean age 66 years) treated with pipeline were reviewed.The aneurysms were unruptured and ranged in size from 1.5 to 3.6cm.The aneurysms were located in the carotid cavernous, carotid ophthalmic, posterior communicating, and supraclinoid.It was reported that there was "proximal end of stent migration" in one patient.There was reportedly no significant neurological sequelae.No further details were provided.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5781443
• MDR Text Key: 49127712
• Report Number: 2029214-2016-00538
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2016
• 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: 06/13/2016
• 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 Age: 66 YR