MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-500-20

Device Problem Activation Failure (3270)

Patient Problem Nerve Damage (1979)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

Based on the customer¿s photo, the clinical observation of failure to open was confirmed.The device was not returned for analysis as it remains in the patient; therefore the event cause could not be determined.In this case, there was severe vessel tortuosity and the device was deployed on a curve.Therefore, the possible cause of middle section not opening could be patient anatomy.Per our instructions for use (ifu), "do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis¿.Information received from the same report as mfr: 2029214-2016-00772.

Event Description

Medtronic received information that during treatment of an aneurysm located in the left internal carotid artery (ica), two pipeline devices did not open properly as the patient had severe vessel tortuosity and the devices were deployed on a curve.It was reported that the doctor began deployment of first device (ped-500-18) using the triaxial system.Multiple attempts to unsheathe the device were made and the best outcome was 60% of the distal end opening of its maximum diameter, while the proximal unsheathed stent end opened up to 70%.The middle section was unable to be opened despite two attempts to unsheathe the device.It was further reported that approximately less than 50 % of the pipeline was deployed when it failed to open.After almost an hour the device and microcatheter were removed together and discarded.A second device was deployed (ped-500-20).It was reported that the doctor attempted to deploy the device, also using the triaxial system.The physician made multiple attempts to unsheathe the device; however the best outcome was 90 % of distal and proximal ends opened of its maximum diameter.The middle section opened up to about 20%.It was further reported that the physician performed balloon angioplasty using a competitor's balloon and within three minutes the balloon ruptured.The physician then realized that a thrombus formed at the distal end of the pipeline flex (ped-500-20) which comprised flow through the left (ica).The physician proceeded with thrombolytic therapy.The thrombus resolved successfully after 30 minutes of detection.The physician decided to leave the stent at its state of narrow neck (about 2mm) due to the risk of further complications for attempt to open stent.The stent remains in the patient without complete wall apposition, with a 2 mm neck in the middle section, the stent however apposed successfully to the wall of aneurysm site, and at both ends (distal <(>&<)> proximal).Patient experienced weakness on right arm after regaining consciousness.All symptoms resolved and the patient was discharged 3 days later.The aneurysm was saccular with the max diameter of 2.99 mm and the neck diameter was 0.5 mm.The distal landing zone was 3.93 mm and the proximal was 4.91 mm.Dapt was administered.Pru levels are unknown.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5926572
• MDR Text Key: 53899123
• Report Number: 2029214-2016-00773
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 08/06/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2019
• Device Model Number: PED-500-20
• Device Lot Number: A254713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2016
• Initial Date FDA Received: 09/02/2016
• Supplement Dates Manufacturer Received: 08/06/2016
• Supplement Dates FDA Received: 09/25/2017
• Date Device Manufactured: 04/04/2016
• 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; Required Intervention
• Patient Age: 40 YR