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

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

Patient Problems Death (1802); Therapeutic Response, Decreased (2271)

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis, as it was implanted in the patient.Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the device occurred during its use.There is no evidence suggesting that the device was defective, but rather a patient condition and post procedure related event.The exact cause of the death and persistence aneurysm filling remains unknown.Death is a known inherent risk of the endovascular procedure and is documented in our device¿s instructions for use (ifu).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

Citation: "low frequency of delayed ischemic events on mri after flow diversion for intracranial aneurysms".Saul f.Morales-valero, waleed brinjikji, john t.Wald , giuseppe lanzino.Medtronic received the following death report: a patient with one a giant verterbo-basilar junction aneurysm with persistent filling after placement of a flow-diverter, was found unresponsive by relatives 25 months after treatment.

• Brand Name: PIPELINE
• 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 ; 9492753836
• MDR Report Key: 6792922
• MDR Text Key: 82636159
• Report Number: 2029214-2017-00970
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Death