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

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

Patient Problems Hemorrhage, Cerebral (1889); Thromboembolism (2654)

Event Date 01/20/2011

Event Type  Injury  

Manufacturer Narrative

The devices were not returned for analysis, as they were successfully implanted in the patients.Hemorrhages and thrombosis events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and patient condition related event.Linked: 2029214-2018-00324.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through literature review of ¿the role of the pipeline embolization device for the treatment of dissecting intracranial aneurysms¿.One patient presented with a retroperitoneal hematoma, and 1 experienced a thromboembolic complication (ipsilateral cerebellar stroke after stent placement and coiling of a giant partially thrombosed vertebral dissecting aneurysm), both with complete recovery.Residual deficits were related to neurologic conditions preceding treatment.Two patients died from late complications of sah.There was no sign of aneurysm rupture following treatment with ped in this series.

• 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: 7450423
• MDR Text Key: 106153083
• Report Number: 2029214-2018-00325
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• 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: 03/26/2018
• 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