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 Intracranial Hemorrhage (1891); Thromboembolism (2654)

Event Date 08/20/2016

Event Type  Injury  

Manufacturer Narrative

Citation: quantitative assessment of parent vessel and distal intracranial hemodynamics following pipeline flow diversion.Results f rom a single center, interventional neuroradiology, 2017, vol.23(1) 34¿40 sophia f shakur, victor a aletich, sepideh amin-hanjani et.Al 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 events occurred in the patients post-procedure and its cause was unknown.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

Medtronic received information from literature of complications after pipeline implantation.The purpose of the article was to evaluate the association between delayed ipsilateral intraparenchymal hemorrhage and endovascular treatment of cerebral aneurysms.The authors reviewed 18 patients who underwent pipeline embolization device (ped) implantation.All patients were female; mean age was 55 years.The aneurysms were unruptured and median size was 7 mm.The article stated that one patient experienced delayed ipsilateral intraparenchymal hemorrhage(iph) after ped deployment.The article also stated that another patient experienced thromboembolic complications with subsequent intracerebral hemorrhage.A single ped was deployed in each of these patients.

• 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 ; 9498373700
• MDR Report Key: 6435888
• MDR Text Key: 70906028
• Report Number: 2029214-2017-00222
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• 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): Other