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

Model Number PED-450-20

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 06/07/2016

Event Type  Death  

Manufacturer Narrative

The pipeline device will not be returned for analysis as it was implanted in the patient.The cause of the post-procedure iph was not reported.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.

Event Description

Medtronic received information that a patient experienced an intraparenchymal hemorrhage after pipeline implantation.It was reported that the pipeline was implanted in the left internal carotid artery (ica).There were no device issues reported during the procedure.The patient was reportedly doing well immediate post-implant.However, the patient's p2y12 began to fluctuate over the days after.The physician adjusted the patient's plavix dosage to control the abnormalities.The patient unexpectedly arrived in the emergency department (ed) with severe a intraparenchymal hemorrhage.

Manufacturer Narrative

Outcome and date of death - additional information.Event description - additional information.Brand name - additional information.Model - correction.Expiration date, lot, udi - additional information.Implanted date - additional information.Pma - correction.Type of reportable event - additional information.Device manufacturing date - additional information.The device model was provided, therefore the model and pma were corrected.The cause of the post-procedure iph and death were not reported.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.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

Medtronic received additional event information: it was reported that the patient's p2y12 began to fluctuate over the days after pipeline flex implantation.Five days post-procedure, the patient's p2y12 was 28.The physician adjusted the patient's plavix dosage to control the abnormalities; the patient was also prescribed acetylsalicylic acid (asa) 325mg.It was reported that twelve days post-procedure, the patient unexpectedly arrived in the emergency department (ed) with severe intra parenchymal hemorrhage in the left frontal lobe.The patient received an external ventricular drain (evd).The patient 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: 5768027
• MDR Text Key: 48711521
• Report Number: 2029214-2016-00497
• 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: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2018
• Device Model Number: PED-450-20
• Device Lot Number: A081543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Date Device Manufactured: 03/30/2015
• 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; Hospitalization
• Patient Age: 54 YR