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

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

Patient Problem Foreign Body Reaction (1868)

Event Date 06/01/2015

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.Gadara, m.(2015).Intracerebral granulomas after pipeline embolization device procedure for intracranial aneurysms; two case reports.J neuropathol exp neurol journal of neuropathology <(>&<)> experimental neurology, 74(6), 630.Doi:10.1097/nen.0000000000000205 mdrs related to this article: 2029214-2016-00557 2029214-2016-00558 2029214-2016-00559.

Event Description

Medtronic review of literature found reports of foreign body giant cell reaction and granulomas of the brain parenchyma after pipeline implantation.A patient presented with incidental bilateral paraclinoid aneurysms, which were treated four weeks apart by pipeline-supported coil embolization.Eight weeks later, mri showed bilateral predominantly subcortical enhancing lesions, with very little surrounding edema.Extensive rheumatologic and infectious disease evaluations were all negative.Follow-up mri over the next 18 months showed increased lesions in number and size.A biopsy of the left frontal lobe showed foreign body giant cell reaction and granulomas within small intraparenchymal blood vessels and subcortical white matter.Many granulomata contain foreign material.The patient was treated with a steroid.An mri was performed 3 months later which demonstrated a decrease in number and size of enhancing nodules.

Manufacturer Narrative

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

• 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: 5784242
• MDR Text Key: 49231505
• Report Number: 2029214-2016-00557
• 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,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• 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): Other
• Patient Age: 54 YR