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

Model Number PIPELINE

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

Patient Problems Hematoma (1884); Hemorrhage, Subarachnoid (1893); Tachycardia (2095)

Event Date 05/03/2012

Event Type  Injury  

Event Description

Information received from the article: akbari sh, reynolds mr, kadkhodayan y, et al.Hemorrhagic complications after prasugrel (effient) therapy for vascular neurointerventional procedures.J neurointervent surg 2013;5:337ã¢â¿¬â¿¿343.Medtronic (covidien) received information from literature review stating that seven patients underwent pipeline embolization device (ped) placement for treatment of aneurysms received aspirin and clopidogrel treatment, while seven other patients that underwent pipeline embolization device (ped) placement for treatment of aneurysms received aspirin and prasugrel treatment.In the aspirin/clopidogrel group, one patient had hemorrhagic complication.The patient had an aneurysm located in the cavernous segment of the left ica (internal carotid artery).Five days post pipeline procedure, the patient presented with headache and was found to have an anterior interhemispheric subarachnoid hemorrhage.In the aspirin and prasugrel group, 2 patients had hemorrhagic complications.One patient presented for elective placement of pipelines to the right cavernous segment.The procedure was complicated by perforation of the proximal right cervical carotid artery with active contrast extravasation and development of a right neck hematoma.Several pipelines were quickly deployed across the aneurysm neck; an additional pipeline was placed across the perforated segment to control the hemorrhage.A non-contrast neck ct (computed tomography) showed soft tissue stranding and likely hemorrhage adjacent to the internal carotid artery.The patient remained intubated and was transferred to the intensive care unit.Two days post procedure, the patient became hemodynamically unstable and was found to have a large rectus sheath and right groin hematoma.The patient was taken to the operating room with vascular surgery for placement of a covered lliofemoral stent for hemorrhage control.Three days post procedure, the patient was restarted on full dose aspirin and prasugrel.The same day, the patient was noted to be less responsive, tachypnea and tachycardic.Chest ct demonstrated large bilateral pulmonary emboli.The patient was started on a bivalirudin intravenous drip and extubated on five days post procedure.Coumadin therapy was started for deep venous thrombosis and pulmonary emboli.He was discharged to a rehabilitation facility 15 days post procedure and had a meaningful neurological recovery.The other patient underwent placement of multiple pipelines across the aneurysm neck without complications.Full dose aspirin and prasugrel were continued one day post procedure.The hospital course was uncomplicated and the patient was discharged home three days post procedure.One month after the procedure, the patient was admitted to the intensive care unit with an upper gastrointestinal bleed and severe anemia requiring transfusion with 6 units of packed red blood cells.Upper endoscopy showed gastric erosion that was treated by thermocoagulation.The patient¿s antiplatelet regimen was held.A head ct performed at this time showed an asymptomatic right frontal intraparenchymal hemorrhage.The patient was started on ticlopidine (250 mg orally twice daily) and later discharged in a stable condition.The information was received from the same article as mdr# 2029214-2015-00338.

Manufacturer Narrative

The report was created to capture the complications reported in the article: information received from the article: akbari sh, reynolds mr, kadkhodayan y, et al.Hemorrhagic complications after prasugrel (effient) therapy for vascular neurointerventional procedures.J neurointervent surg 2013;5:337â⿬⿿343.Http://dx.Doi.Org/10.1136/neurintsurg-2012-010302.The devices will not be returned as they were implanted in the patients.The lot histoy record review was not possible as the lot numbers were not reported (b)(4).

• 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: 4659525
• MDR Text Key: 5731812
• Report Number: 2029214-2015-00340
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PIPELINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Disability