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); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982); Paresis (1998); Visual Impairment (2138); Thromboembolism (2654)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

World neurosurg.2017 jul 13.Pii: s1878-8750(17)31119-1.Doi: 10.1016/j.Wneu.2017.07.019.Safety and efficacy of a 600 mg loading dose of clopidogrel 24 hours before pipeline embolization device treatment.Atallah e, saad h, bekelis k, chalouhi n, tjoumakaris s, hasan d, zarzour h, smith m, rosenwasser rh, jabbour p the pipeline devices will not be returned for evaluation as they were implanted in the patients.Based on the provided information, there does not appear to have been any defects of the devices during use.The events occurred in the patients post-procedure and the cause could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01021.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 literature review found reports of patient thromboembolic events and hemorrhagic events after pipeline implantation.The purpose of this article was to assess the safety and efficacy of a 600-mg loading dose of clopidogrel 24 hours before pipeline embolization device (ped) treatment when compared to the standard antiplatelet administration 7-10 days before treatment.The authors retrospectively reviewed 398 patients (mean age was 56.36 years; 66 female; 332 male) undergoing ped flow diversion.The patients were separated into two groups: 158 patients received a dapt bolus <(><<)>24 hours preceding the procedure and 240 patients received standard dual antiplatelets for 7-10 preceding the procedure.Of the 398 patients, the authors noted the following outcomes: - 32 patients experienced thromboembolic complications.The article states that of these 32 patients, 17 patients were from the bolus group and their thromboembolic events manifested within less than 1-month follow-up: 4/17 experienced permanent neurologic deficit (ranging from extremity weakness to complete hemiparesis) and 13/17 experienced minor transient neurologic symptoms (visual floaters, minimal limb weakness, numbness, or speech difficult) which resolved on the latest follow-up.- 15 patients experienced hemorrhagic complications.The article states that of these 15 patients, 6 patients were from the bolus group: 3 experienced small right temporal and frontal bleeding with minimal neurologic sequelae and 3 experienced minor sah with minimal neurosequelae on latest follow-up.

• 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: 6851934
• MDR Text Key: 85351897
• Report Number: 2029214-2017-01022
• 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: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/14/2017
• Initial Date FDA Received: 09/08/2017
• 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): Other