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

Model Number FA-77375-12

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

Patient Problem Hematoma (1884)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the provided information, the report of foreign body emboli could not be confirmed and the cause of the event could not be conclusively determined.Shapiro, m.Et al.(2015, august 20).Foreign body emboli following cerebrovascular interventions: clinical, radiographic, and histo pathologic features.American journal of neuroradiology, 36(11), 2121-2126.Doi:10.3174/ajnr.A4415 mdrs related to this article: 2029214-2016-01084, 2029214-2016-01087, 2029214-2016-01088.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 that a patient was suspected to have foreign body emboli after pipeline implantation.The patient underwent uneventful coil-supported pipeline embolization of a right paraophthalmic aneurysm.It was reported that the patient was tired during the next 2 months.On week 8 post-embolization, she developed sudden headache and neck pain while watching a foreign movie and noticed difficulty reading the subtitles.Neurologic examination revealed left inferior homonymous quadrantanopsia.Ct and mr imaging demonstrated a 2 to 3 cm right parieto-occipital hematoma, with multiple subcortical enhancing lesions scattered throughout the ipsilateral hemisphere.The clopidogrel dosage was titrated to an empiric range of 100¿200 p2y12 reaction units (pru).After an 8-week course of dexamethasone, mr imaging showed near-complete resolution of perilesional edema and decreased lesion enhancement, with no new lesions.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6144057
• MDR Text Key: 61395913
• Report Number: 2029214-2016-01087
• 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,Followup
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77375-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2016
• 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