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

Device Problem Difficult To Position (1467)

Patient Problems Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.The event could not be confirmed and an event cause could not be conclusively determined from the reported information.Park, m.S.(2016).Re-treatment rates after treatment with the pipeline embolization device alone versus pipeline and coil embolization of cerebral aneurysms: a single-center experience.Journal of neurosurgery, 125(1), 137-144.Doi:10.3171/2015.7.Jns15582 mdrs related to this article: 2029214-2016-00683 2029214-2016-00684 2029214-2016-00685 2029214-2016-00686 2029214-2016-00687 2029214-2016-00688 2029214-2016-00689 2029214-2016-00690 2029214-2016-00691 2029214-2016-00692 2029214-2016-00693 2029214-2016-00694 2029214-2016-00695 2029214-2016-00696 2029214-2016-00697 2029214-2016-00698 2029214-2016-00699 2029214-2016-00700 2029214-2016-00701 2029214-2016-00702 2029214-2016-00703 2029214-2016-00704 2029214-2016-00705 2029214-2016-00706 2029214-2016-00707 2029214-2016-00708 2029214-2016-00709 2029214-2016-00710 2029214-2016-00711 2029214-2016-00712 2029214-2016-00713 2029214-2016-00714 2029214-2016-00715.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report of thrombosis during a pipeline procedure as well as retreatment.The patient had an aneurysm recurrence after clip ligation.The aneurysm was 3mm and was located in the posterior communicating artery (pcoa) and had significant luminal narrowing of the ophthalmic internal carotid artery (ica).The patient experienced acute thrombus formation and occlusion of the anterior cerebral artery requiring thrombolysis.Due to the parent's anatomy and procedural complications, the pipeline was deployed with inadequate coverage of the aneurysm neck.The patient was stabilized following the procedure and returned the following day for placement of an additional device.

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: 5855651
• MDR Text Key: 51443978
• Report Number: 2029214-2016-00709
• 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: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 07/12/2016
• 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
• Patient Age: 48 YR