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

Model Number NOT REPORTED

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Information received from the article: boddu sr, tong fc, dehkharghani s, et al.Contrast-enhanced time-resolved mra for follow-up of intracranial aneurysms treated with the pipeline embolization device.Ajnr.2014 nov; 2112-2118.During a period of two years, 26 patients had intracranial aneurysms that were treated with a total of 37 pipeline embolization devices.A 3d-tof mra (magnetic resonance imaging), contrast-enhanced time-resolved mra, and dsa (digital subtraction angiography) were used in the initial follow-up of the patients.All patients underwent dsa an average of 0 days (range, 0¿68) after mra.Studies were evaluated for aneurysm occlusion, quality of visualization of the reconstructed artery, and measurable luminal diameter of the pipeline embolization device, with dsa used as the reference standard.One patient was suffering from a right cavernous carotid aneurysm.The patient underwent pipeline embolization treatment and post procedural images showed stasis within the aneurysm.At 6-month follow-up, images showed complete opacification of the aneurysm with no stasis or thrombus.Distal migration of the pipeline was diagnosed on ce-tr mra and confirmed on dsa; the aneurysm neck reopened with refilling of the entire aneurysm as a result of the migration.No other information regarding patient condition was presented in the article.

Manufacturer Narrative

The lot history record review was not possible as the lot number was not reported.The device will not be returned for analysis as it was implanted in the patient; therefore, the event cause could not be determined.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN; 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 ; 9496801558
• MDR Report Key: 4391141
• MDR Text Key: 14879374
• Report Number: 2029214-2015-00004
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2014

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
• Device Model Number: NOT REPORTED
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 01/07/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR