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

Model Number PED-500-35

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

Patient Problem Brain Injury (2219)

Event Date 07/04/2016

Event Type  Death  

Manufacturer Narrative

The pipeline flex device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2016-00757, 2029214-2016-00758, 2029214-2016-00759.

Event Description

Medtronic received report that a patient experienced infarction after pipeline flex implantation.The patient was undergoing treatment for an unruptured, fusiform aneurysm in the basilar artery.The max.Diameter was 2.5cm and neck diameter was 2cm.Vessel tortuosity was normal.All devices were prepared as indicated in the ifu.Dual antiplatelet treatment was administered; blood tests indicated that the patient is responsive to aspirin and clopidogrel.Three pipeline flex devices were implanted in a telescoping manner from 5mm below the basilar tip to the junction of the vertebral arteries.The aneurysm was then filled with non-medtronic coils.There were no issues noted during the procedure.Two hours after the procedure, the patient experienced bilateral infarction of the cerebellum.The physician reports that the infarction was not caused by the pipeline devices, but is a risk of the treatment.The patient was admitted to intensive care and later passed away.

Manufacturer Narrative

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.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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 ; 9496801224
• MDR Report Key: 5912181
• MDR Text Key: 53436118
• Report Number: 2029214-2016-00757
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2017
• Device Model Number: PED-500-35
• Device Lot Number: A022851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Date Device Manufactured: 11/25/2014
• 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
• Patient Age: 58 YR
• Patient Weight: 95