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

Model Number FA-77475-14

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Date 12/08/2011

Event Type  Injury  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2017-00258, 2029214-2017-00259.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 experienced intraprocedural thrombus during placement of a pipeline device.The article states that the patient was undergoing treatment for a posterior inferior cerebellar artery (pica).The aneurysm size was 7mm.The aneurysm was 10mm in size.There were no device issues noted during implantation.The article states that the patient experienced distal embolization to a branch of the middle cerebral artery (mca) during pipeline placement.Abciximab (15mg) was administered and the clot resolved completely.Post-procedure, the patient experienced mild aphasia, which resolved within 24 hours without permanent deficits.On follow-up, all patients reviewed in this article had a glasgow outcome scale of 5.Deutschmann, h.A.Et al.(2011).Long-term follow-up after treatment of intracranial aneurysms with the pipeline embolization device: results from a single center.American journal of neuroradiology, 33(3), 481-486.Doi:10.3174/ajnr.A2790.

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: 6441571
• MDR Text Key: 71094357
• Report Number: 2029214-2017-00259
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-77475-14
• Device Lot Number: XJA07-627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• 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): Required Intervention
• Patient Age: 48 YR