MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 2.50MM X 16MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-250-16

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation and analysis is anticipated.A supplemental will be submitted upon completion.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 information that during pipeline treatment for an aneurysm located in the anterior communicating artery (acom), the pushwire detached at the hypotube proximal to the wire weld.It was reported that while advancing the pipeline device resistance was encountered in the middle and distal segment of the microcatheter, as the patient had very tortuous anatomy; therefore a lot of effort was made in pushing the pushwire.The pipeline device and pushwire were withdrawn from the patient within the microcatheter successfully.A new pipeline was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

The pipeline flex delivery system and the microcatheter were returned for evaluation.The pipeline flex delivery system was found outside of the catheter.The catheter body was found to have accordion damage.It appeared that the pipeline flex pushwire was detached at the hypotube proximal to the wire weld.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pushwire was observed to be bent.The pipeline braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified.The ends of the pipeline braid were found fully opened with no damage.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 analysis findings it is likely that the pushwire detached due to tensile failure.The damages seen on the returned catheter body (accordioning), proximal wire (bending) and hypotube (stretching); suggest that excessive forced used such as pushing and pulling.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.In addition, 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.It is possible that the ¿severe vessel tortuosity¿ may have contributed to the ¿resistance during delivery¿; subsequently causing the devices to become damaged and detached.In this event, the user may have contributed to the reported issues as the physician continued to advance the pipeline flex delivery system despite resistance.Per the pipeline flex instructions for use: ¿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.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.¿ additionally, a review of this device lot history record was conducted and no issues were identified that could have contributed to this event.All products are 100% inspected for damage and irregularities.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX 2.50MM X 16MM
• 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: 6074529
• MDR Text Key: 59042885
• Report Number: 2029214-2016-00971
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: PED-250-16
• Device Lot Number: A113422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided; 11/16/2016
• Supplement Dates FDA Received: 12/08/2016; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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 Age: 64 YR
• Patient Weight: 70