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

Model Number PED-375-14

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) the pipeline flex will not be returned as it was implanted in the patient.Based on the reported information, there did not appear to have been any device issue during use.The reported ipsilateral hemorrhage is located distal to the pipeline implants.Intracerebral bleeding is a known inherent risk of pipeline procedure and is documented in the pipeline flex instruction for use.The event occurred in the patient post-procedure and its cause cannot be determined from the reported information.It should be noted that the physician used the pipeline flex to treat a blister aneurysm.Per the pipeline flex instructions for use (ifu): ¿the pipeline flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.¿ mdrs related to this event: 2029214-2016-00123 2029214-2016-00124.

Event Description

Medtronic received report that a patient experienced remote ipsilateral hemorrhage two days after pipeline flex implantation.The patient received two pipeline flex implants to treat a blister aneurysm (diameter ~2mm) in the distal right internal carotid artery (ica) immediately proximal to aca.The aneurysm had previously ruptured three months before and was not treated at that time.The physician chose to implant two pipeline flex devices for improved proximal coverage; the physician felt that the previously ruptured aneurysm could benefit from two devices.There was reportedly no difficulties during the implantation procedure.Two days post-procedure, the patient experienced an ipsilateral intraparenchymal hemorrhage (iph) in the posterior superior area of the right hemisphere.The patient presented in the er and was given platelets.The patient had an nihss of 16.The patient is reported to be doing slightly better since the iph.

• 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: 5467811
• MDR Text Key: 39281830
• Report Number: 2029214-2016-00124
• 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
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2018
• Device Model Number: PED-375-14
• Device Lot Number: A183383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Date Device Manufactured: 11/04/2015
• 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): Hospitalization
• Patient Age: 00071 YR