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

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

Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Visual Impairment (2138)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis as it was implanted in the patient.Attempts have been made to obtain additional information.However, our attempts have been unsuccessful.There is no evidence of a device malfunction as the device was successfully implanted.Based on the reported information, these events occurred after the device was used successfully.The cause of the in-stent stenosis, stoke, neurological events and the hemorrhage, cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the complaint, the most likely cause for the complaint is the patient condition, changes in the blood flow and medication regimen.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

Citation: p2y12 hyporesponse (pru>200) is not associated with increased thromboembolic complications in anterior circulation pipeline.Bender mt1, lin lm2, colby gp1, lubelski d1, huang j1, tamargo rj1, coon al1.J neurointerv surg.2016 sep 6.Pii: neurintsurg-2016-012618.Doi: 10.1136/neurintsurg-2016-012618.[epub ahead of print] medtronic received the following report: patients average age was 57 (39 female out of 52).Acute in-stent thrombosis requiring abciximab was seen in 3 cases after ped deployment.None of these patients had neurological deficits post procedurally.All procedures were successfully completed.One major stroke occurred in a patient who underwent left anterior cerebral artery (aca) ped placement for a 4 mm recurrent anterior communicating artery aneurysm.The patient developed hemiparesis on post-embolization day 2 and was found to have stent thrombosis, which was managed conservatively owing to concern about hemorrhagic conversion of the left aca territory stroke.Minor complications: one patient developed visual field cut and transient expressive aphasia 2 days after the operation with an associated area of restricted diffusion in the left medial occipital lobe on mri; one patient had a small (<(><<)>10 cc) right frontal intracranial hemorrhage (ich) with associated transient left lower extremity weakness.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6428528
• MDR Text Key: 70684998
• Report Number: 2029214-2017-00211
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• 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
• Was Device Evaluated by Manufacturer?: No
• 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