MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 01/01/2017

Event Type  Death  

Manufacturer Narrative

The pipeline device has not been returned for evaluation as it remained implanted in the patient.The reported event could not be confirmed and an event cause could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-00453 2029214-2017-00454.

Event Description

Medtronic literature review found a report of a patient death after pipeline implantation.The purpose of this abstract was to evaluate the safety and effectiveness of the pipeline in the treatment of giant intracranial aneurysms.The authors reviewed the cases of 33 patients who underwent treatment for 35 aneurysms.There were no device issues noted in the abstract.The abstract states that the pipeline devices were successfully released during all cases.The abstract states that one patient died of delayed aneurysm bleeding.Feng, m.Et al.Effect analysis of embolization device for the treatment of large or giant intracranial aneurysms.[abstract].In: chinese journal of cerebrovascular diseases.14 (1) (pp 32-36), 2017.Date of publication: january 2017.

• Brand Name: PIPELINE EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6496672
• MDR Text Key: 72876172
• Report Number: 2029214-2017-00454
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/16/2017
• 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