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

Model Number PED-375-16

Device Problem Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.Information received from the same report as mfr: 2029214-2016-00412.

Event Description

Medtronic received information that during treatment of an aneurysm a fracture was noted at the distal marker of two delivery wires.It was reported that during delivery the (ped-375-16) device became stuck within the microcatheter.In the second attempt the initial part was pushed out, but further deployment was not possible and the device was unable to be resheathed.The device was removed from the patient and a fracture was noted on the delivery wire.A second device (ped2-375-18) was used and reported to have the same issue.No patient injury was reported.

Manufacturer Narrative

The pipeline flex pushwire and the microcatheter were returned for evaluation.It appeared that the pipeline flex pushwire was detached at the hypotube proximal to the wire weld.The detached distal segment of the pushwire and pipeline braid were found outside of the catheter.The remaining segment of the pushwire was found inside of the microcatheter.The catheter body was found to be accordioned.For further examination, the remaining segment of the pushwire was then pushed out of the catheter lumen with difficulty.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The pipeline braid was found fully opened with moderately fraying at both ends.The pushwire was observed to be bent.No other anomalies were observed.The surfaces of the detached pushwire were sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) analyses.Based on the reported event details, the analysis findings and the sem/eds analyses, the clinical observation was confirmed.We are unable to definitively determine the cause of the reported experience.The elemental analysis conducted through scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) showed presence of soldering material (tin); thereby indicating that the soldering was conducted.In addition, a review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.However, the damages observed on the pushwire proximal wire, pipeline braid, hypotube and catheter body suggest excessive force such as pushing and pulling.It is possible that the ¿moderate vessel tortuosity¿ may have contributed to the ¿gradual resistance¿; subsequently causing the devices to become damaged and detached.However, the cause for the resistance could not be determined.In this event, the user context may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system despite of the resistance.Per our instructions for use, the user should "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.All products are 100% inspected for damage and irregularities during manufacture.

• 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: 5737162
• MDR Text Key: 47793532
• Report Number: 2029214-2016-00413
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2018
• Device Model Number: PED-375-16
• Device Lot Number: A122258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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