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 Problem Failure of Implant (1924)

Event Date 07/10/2015

Event Type  Injury  

Event Description

Medtronic (covidien) received information that from literature review that one patient with mrs 6, one had a giant vertebro-basilar junction aneurysm with persistent filling after placement of a flow diverter, who was found unresponsive by relatives 25 months after treatment.The purpose of the study was to evaluate the occurrence rate of silent ischemia detected on mri in patients undergoing treatment of intracranial aneurysms with ped receiving at least 6 months of mri follow up.Of the 68 patients with mri following aneurysm treatment with ped, 60 patients had an mri at least six months following treatment with the ped.Citation: morales-valero sf, brinjikji w, wald jt, et al.Low frequency of delayed ischemic events on mri after flow diversion for intracranial aneurysms.J neurosurg sci.2015 jul 10.

Manufacturer Narrative

No information was available regarding the cause of death.The lot history record review was not possible since the lot number was not reported.The device will not be returned for analysis as they were 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 (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 4974293
• MDR Text Key: 6336685
• Report Number: 2029214-2015-00859
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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
• Date Manufacturer Received: 07/15/2015
• 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): Other
• Patient Age: 55 YR