MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-425-35

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.Follow up attempts have been made.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the pipeline case, the pushwire was alleged to have kinked and broke when it was advanced.The tip coil was also reported to have broken while removing the device.The pushwire/capture coil got stuck during the retraction.The devices were all reported to have been used per the instructions for use (ifu).The aneurysm was in the internal carotid artery (ica), it was ruptured, and amorphous.The max diameter was 4 mm and the neck was 2mm.The landing zone was 2.7mm distally and 4.5 mm proximally.The anatomy was severely tortuous.There was no patient injury.

Manufacturer Narrative

The device was returned for evaluation and the clinical observation was confirmed.As received, the pipeline flex delivery system stuck within the distal segment of the microcatheter.The pipeline flex was then pushed out from the catheter lumen with difficulty.The distal hypotube was found to be stretched with the ptfe shrink tubing still intact.The pipeline flex pushwire appeared to be detached at the hypotube proximal to the wire weld.Kinks and bends were found on the pushwire at multiple locations from the proximal end.Additionally, the distal and proximal ends of the pipeline flex braid were found fully opened with moderately frayed.No other anomalies were observed.The surfaces of the detached pushwire were then sent out for sem and eds analyses.Based on the analysis findings and the sem/eds analyses, the distal wire of the pipeline flex delivery system was possibly detached due to tensile failure.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.All products are 100% inspected for damage and irregularities during manufacture.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Per our instructions for use (ifu): "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 intralumenal 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.¿ 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): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7565856
• MDR Text Key: 110048720
• Report Number: 2029214-2018-00477
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/27/2018

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 Model Number: PED-425-35
• Device Lot Number: A414762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No
• 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