MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Device Problem Collapse (1099)

Patient Problem Stenosis (2263)

Event Date 06/18/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.Brzezicki, g.(2015).Pipeline embolization device for treatment of high cervical and skull base carotid artery dissections: clinical case series.Journal of neurointerventional surgery j neurointervent surg, 8(7), 722-728.Doi:10.1136/neurintsurg-2015-011653.Mdrs related to this article: 2029214-2016-00586 2029214-2016-00587 2029214-2016-00588 2029214-2016-00589 2029214-2016-00590.

Event Description

Medtronic received information that a patient underwent retreatment after pipeline implantation.The patient initially presented with ear and jaw pain.The patient was found to have a 2x2mm pseudoaneurysm and vessel dissection.In addition, the patient had flow-limiting stenosis (95%).The parent vessel size was 5.2mm proximal and 4.2mm distal to the aneurysm.The patient received two pipeline device implants.The three-month follow-up ct angiography (cta) demonstrated a short segment of 95% stenosis in the cavernous internal carotid artery (ica).One of the pipeline devices was "almost completely collapsed." there was preserved flow around the collapsed device.The patient underwent balloon angioplasty of the collapsed segment which resulted in 50% residual stenosis.

• 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: 5804506
• MDR Text Key: 49885292
• Report Number: 2029214-2016-00587
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• 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: 06/21/2016
• 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 Outcome(s): Required Intervention