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

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

Patient Problems Intracranial Hemorrhage (1891); Ischemia (1942)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis as they were implanted in the patients.Attempts have been made to obtain additional information, however, our attempts were unsuccessful.The flow diverter device performed as intended; as indicated by successful deployment of the device in the intended landing zone to treat an aneurysm located.There was no device issue reported during the procedure.Intracranial hemorrhage and ischemia are known inherent risk of endovascular procedure and is documented in the flow diverter device¿s instruction for use (ifu).In these events, the cause of the intracranial hemorrhage and the ischemic event cannot be reliably determined; however, per the reported information, and review of ifu, the most likely cause for the complaint is the patients¿ condition.Linked events: 2029214-2017-00666 2029214-2017-00667.

Event Description

Citation: ¿flow diversion in ruptured intracranial aneurysms: a meta-analysis¿ t.P.Madaelil, c.J.Moran, d.T.Cross and a.P.Kansagra american journal of neuroradiology march 2017, 38 (3) 590-595; doi: https://doi.Org/10.3174/ajnr.A5030 medtronic received report that the flow diverter (fd) was used to treatment121of 126 patients, competitive flow diverter was used in the remaining 5/126 of cases.Aneurysm re-rupture occurred following fd placement in 6/126 of aneurysms.4 re-ruptures occurred during or within the first 24 hours of treatment.Hemorrhagic complications not related to aneurysm re-rupture occurred in 5/126 of patients.One was an asymptomatic cerebellar hemorrhage.Ischemic complications occurred in 5/111 of patients, of whom 4/111 were symptomatic.Median age was 51 years (interquartile range, 45¿60 years), and 71% of patients were women.

• 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: 6580351
• MDR Text Key: 75615953
• Report Number: 2029214-2017-00667
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2017
• 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: 04/24/2017
• 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): Other