MAUDE Adverse Event Report: COVIDIEN, IRVINE PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Journal of pharmacy practice 2018, vol.31(1) 115-119 ª the author(s) 2017 reprints and permission: sagepub.Com/journalspermissions.Nav doi: 10.1177/0897190017696947 the pipeline embolization devices remain implanted in the patients.Therefore, device evaluation will not be performed.The cause of the post operative complications reported in the article could not be conclusively determined from the available information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from literature review that a patient had stroke like symptoms a few hours post pipeline embolization device(ped) treatment for aneurysms at the right internal carotid artery.The mri revealed multiple cortical shower emboli in the right middle cerebral artery.The patient was treated with intravenous heparin for 5 day, and simultaneously started aspirin and clopidogrel.There were no further thrombotic complication.This patient had been on dapt with ticagrelor two days prior to the procedure.It was later noted that some of the pre-procedural dapt had been omitted and delayed due to patient condition.A second patient in the same article reported a patient experienced in stent thrombosis post pipeline embolization device(ped) placement for a right posterior communication artery aneurysm, although the procedure itself was uneventful.It was reported the day after the ped placement procedure, the patient demonstrated left-sided hemiplegia, and mri showed a small capsular infarct on the right posterior limb of the internal capsule.Platelet function studies including collagen¿epinephrine closing time and collagen¿adenosine diphosphate closing time were performed; neither of which was prolonged., despite the patient had been on clopidogrel prior to the procedure.Ticagrelor was started for the patient.Seven days after the ped was placed, an mri showed the patient had occluded internal carotid artery and there was complete in stent thrombosis.Partial recanalization of the stent was achieved, but the frontal branch of the right mca remained persistently occluded.The patient was discharge from the hospital after several days.The above information is extracted from the retrospective study to evaluate the safety and efficacy of ticagrelor in patients undergoing neurovascular procedures.

• Brand Name: PIPELINE
• 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: 7406818
• MDR Text Key: 104683893
• Report Number: 2029214-2018-00258
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• 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: 03/26/2018
• 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