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); Intracranial Hemorrhage (1891); Ischemia (1942); Thrombosis (2100)

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis as they were implanted in the patients.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, ischemia and death 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: 2029214-2017-00667.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: ¿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 treatment 121 of 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.Two fatal hemorrhagic complications occurred, including 1 after intra-arterial tpa instillation through a microcatheter for intraprocedural thrombosis of the fd, and 1 related to postprocedural hemorrhage distant from the treated aneurysm.There was a 3rd death case with fatal brain stem ischemia.Median age was (b)(6) 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: 6580349
• MDR Text Key: 75591772
• Report Number: 2029214-2017-00666
• 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: Health Professional
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death