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

Model Number PED-450-25

Device Problem Break (1069)

Patient Problems Neurological Deficit/Dysfunction (1982); Foreign Body In Patient (2687)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

The device has been received, however, the evaluation has yet not begun.A supplemental report will be submitted.

Event Description

Medtronic received report that after the device was successfully delivered, it was realized that the device separated at the proximal bumper.The patient was initially asymptomatic, however, a few hours later was reported to have stroke like symptoms.The patient was on antiplatelet medication.The anatomy was moderate to severe.A continuous flush was used during the procedure.It is believed that the separated pushwire may be cause of the post procedure symptoms.

Manufacturer Narrative

The proximal segment of the flow diverter¿s pushwire was returned for evaluation.The braid and the broken distal segment of the pushwire were not returned, as the braid was implanted with the broken distal pushwire.The micro catheter was not returned for evaluation, as it was discarded.The pushwire was found to be separated at the distal hypotube.The hypotube was found to be severely stretched.The pushwire was found to be kinked/ bent near the proximal end.No other anomalies were observed.The broken end of the pushwire was then sent out for scanning electron microscopy (sem) analysis.Based on the analysis findings, the event details and the sem analysis; the report of pushwire break at distal hypotube was confirmed, as the received pushwire was found to be separated at the distal hypotube.The fracture surface features of the broken end are consistent with tensile overload failure.From the damages seen on the proximal wire (kinking/bending) and hypotube (severely stretching); it appears that excessive force was used.It is possible the severe vessel tortuosity may contribute to the excessive force used during procedure; subsequently causing the distal hypotube to become separated.Per our instructions for use: ¿discontinue delivery of the device if high force or excessive friction is encountered.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.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.¿ all products are 100% inspected for damage and irregularities during manufacture.Updated with udi number.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 ; 9492753836
• MDR Report Key: 6916041
• MDR Text Key: 88232442
• Report Number: 2029214-2017-01112
• 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
• Report Date: 10/13/2017

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: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A468652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/05/2017
• Supplement Dates Manufacturer Received: 10/06/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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): Disability