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

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

Patient Problems Infarction, Cerebral (1771); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Citation: mazur md, kilburg c, wang v, et al."pipeline embolization device for the treatment of vertebral artery aneurysms: the fate of covered branch vessels" neurointervent surg.Published on line first 29 september 2015 doi:10.1136/neurintsurg-2015-012040.The 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 was unknown.

Event Description

Medtronic received information through review of literature that one patient (patient 8) developed immediate in-stent stenosis and occlusion of the covered posterior inferior cerebellar artery (pica) after ped deployment; after abciximab administration the in-stent stenosis resolved.The covered (pica) recanalized on follow-up imaging 6 months later (figure 4), and although the patient suffered a (pica) distribution infarction ipsilateral to the treated aneurysm, she recovered to her neurological baseline.In this patient the distal end of the ped was positioned in the basilar artery; therefore, the contralateral vertebral artery (va) ostium was covered.On follow-up, occlusion of the contralateral v4 segment was seen extending from the contralateral (pica) ostium to the basilar artery.The contralateral pica remained patent.This patient presented with subarachnoid hemorrhage from ruptured va aneurysm and treated with ped.This patient received intraprocedural abxiximab followed by dual antiplatelet therapy post procedure.The purpose of this article was to examine the fate of covering the posterior inferior carebellar artery (pica) in patients undergoing placement of a flow-diverting stent for vertebral artery (va) aneurysm.There were a total of 13 patients in this cohort.The mean age of the patients was 52 years (range 39-59 years); six patients were female (55%).

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6444894
• MDR Text Key: 71201524
• Report Number: 2029214-2017-00276
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• 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: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR