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

Model Number PED-325-16

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex braid and part of the pushwire were implanted in the patient.The remainder of the pipeline flex pushwire has been returned and evaluation is currently in progress.A follow up mdr will be submitted when evaluation is complete.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 report that a pipeline flex pushwire broke during a procedure.The patient was undergoing treatment for an unruptured, saccular aneurysm in the right ophthalmic internal carotid artery (ica).The aneurysm had a max diameter of 11.47mm and neck diameter of 5.4mm.Landing zone artery size was 2.58mm distal and 3.23mm proximal.The vessel tortuosity was minimal.The devices were prepared as indicated in the ifu.The pipeline flex was advanced through the catheter; the physician remarked that the force required to push the pipeline flex was noticeably more than usual.It was reported that at deployment of the pipeline flex, the delivery wire broke just proximal to the proximal marker.This occurred once the last part of the pipeline flex was deployed.Multiple attempts were made to recapture the detached wire, including using several snare devices, without success.Finally, another manufacturer's stent was placed overlapping the proximal portion of the pipeline flex, pinning the detached delivery wire against the vessel wall.Post-procedure angiographic result showed that the pipeline flex is apposed to the vessel wall and visible stasis in the aneurysm.The patient is reportedly fine and was discharged one day post-procedure.

Manufacturer Narrative

Additional information the proximal section of the pipeline flex pushwire was returned for evaluation with the catheter.As received, the proximal segment was found outside the catheter.It was confirmed that the pushwire was separated at the distal hypotube.The hypotube was found to be severely stretched.Based on the analysis findings and provided information, the report of pipeline flex pushwire separation was confirmed.The fracture surface features of the broken end are consistent with tensile overload.It is possible that the reported resistance during delivery may have contributed to the reported issues, subsequently causing the pipeline flex delivery system to become damaged.The damage observed on the hypotube (stretching) suggests that excessive force used.In this event, user error may have contributed as it was reported that ¿excessive force¿ was required to advance the pipeline flex.Per our instructions for use: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿ the lot history record of the reported lot number was reviewed and no discrepancies that might have caused the reported event were noted.All products are 100% inspected for damage and irregularities during manufacture.

Manufacturer Narrative

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: 5648580
• MDR Text Key: 44993728
• Report Number: 2029214-2016-00296
• 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: 04/18/2016

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: 01/10/2019
• Device Model Number: PED-325-16
• Device Lot Number: A210313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided; 05/19/2016
• Supplement Dates FDA Received: 06/09/2016; 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2016
• 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): Required Intervention
• Patient Age: 65 YR