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

Model Number PED-475-20

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 09/24/2016

Event Type  Death  

Manufacturer Narrative

The pipeline flex will not be returned as it was implanted in the patient.Based on the reported information, there did not appear to be any device during implantation.The event occurred in the patient post-procedure and an event cause could not be conclusively determined from the reported information.

Event Description

Medtronic received report that a patient experienced intraparenchymal hemorrhage four days after pipeline flex implantation.The patient had received the pipeline flex to treat an unruptured, fusiform aneurysm in the right internal carotid artery (ica).The aneurysm max.Diameter was 6mm.Landing zone artery size was 4mm distal and 4.75mm proximal.Vessel tortuosity was moderate.The pipeline flex was implanted with good placement and wall apposition.The patient was administered dual antiplatelet treatment.Four days post-procedure, the patient reportedly experienced a massive intraparenchymal hemorrhage.The patient presented in the er with pru of 4.At the time of the procedure, the patient's pru was approximately 90.The patient has since passed away.

Event Description

Medtronic received additional event information: after presenting in the er with intraparenchymal hemorrhage (iph), the patient was admitted to the intensive care unit (icu).There was no medical or surgical intervention noted.

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: 6042505
• MDR Text Key: 57914185
• Report Number: 2029214-2016-00924
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2018
• Device Model Number: PED-475-20
• Device Lot Number: A143464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Date Device Manufactured: 08/06/2015
• 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: 53 YR