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

Device Problem Restricted Flow rate (1248)

Patient Problems Ischemia (1942); Paresis (1998)

Event Type  Injury  

Event Description

Information received from the article: keskin et al.Endovascular treatment of complex intracranial aneurysms by pipeline flow-diverter embolization device: a single-center experience.Neurological research.2015;37(4): 359-365.Medtronic (covidien) received information through literature review regarding adverse events and the manufactured products involved with them.Twenty-four patients (mean age 50, 14 female) were treated between april 2012 and december 2013.One patient with a vertebrobasilar aneurysm had 4 overlapping pipelines placed and developed a small ischemic area in the anterior surface of the medulla oblongata probably due to perforating vessel obstruction covered by the ped.The patient deteriorated at postoperative fourth hour and developed left sided hemiplegia.The patient is currently stable without any additional deterioration.One patient stopped taking antiplatelet therapy against medical advice at 2 months and the pipeline became occluded.The patient had no symptoms and antiplatelet therapy was not prescribed again.The patient has been under follow-up for 22 months without any problems.The article concludes that treatment of vertebrobasilar fusiform aneurysms via the pipeline poses some difficulties due primarily to complex structure of these aneurysms.During this review and study, parent artery reconstruction via flow diversion with the pipeline embolization device is a valid and safe form of treatment with low morbidity for wide necked complex aneurysms and also the aneurysms which are not amenable for standard coiling procedures including small aneurysms.

Manufacturer Narrative

The report was created to capture the complications from the review in the article: keskin et al.Endovascular treatment of complex intracranial aneurysms by pipeline flow-diverter embolization device: a single-center experience.Neurological research.2015;37(4): 359-365.The lot history review was not possible as the lot numbers were not reported.The devices involved in the event will not be returned for evaluation as they were implanted in the patient.

Manufacturer Narrative

Corrected to serious injury.

• 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: 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4553861
• MDR Text Key: 22066075
• Report Number: 2029214-2015-00211
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Disability
• Patient Age: 50 YR