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

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

Patient Problems Death (1802); Hematoma (1884)

Event Date 08/24/2017

Event Type  Death  

Manufacturer Narrative

Brasiliense lbc, aguilar-salinas p, miller da, tawk rg, sauvageau ea, hanel ra, analysis of predictors and probability of aneurysm occlusion in the ica after treatment with pipeline embolization device, world neurosurgery (2017), doi: 10.1016/j.Wneu.2017.08.099.The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there does not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01193 2029214-2017-01194.

Event Description

Medtronic literature review found reports of a patient death after pipeline implantation.The purpose of this study was to investigate predictors and rate of occlusion for aneurysms along the internal carotid artery (ica).The authors analyzed the results of 83 patients with 117 aneurysms who underwent treatment with the pipeline embolization device (ped); a total of 106 peds were deployed.The patients¿ mean age was 61.2 years; 75 of the patients were female.The article notes that three patients died sometime after ped implantation.Of the three deaths, only one death may have been related to the ped: the patient ((b)(6), male) died approximately 50 days after treatment following recurrent subdural hematomas likely secondary to the antiplatelet regimen.

• 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: 6986255
• MDR Text Key: 90508206
• Report Number: 2029214-2017-01194
• 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: 10/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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: 10/03/2017
• 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): Death
• Patient Age: 79 YR