MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-250-20

Device Problems Positioning Failure (1158); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex with shield (ped2) embolization device and the catheter were returned.The ped2 delivery system and catheter were decontaminated.Upon visual inspection of the catheter, no damages were found with the hub or distal tip.The ped2 pushwire was found extending from the catheter hub.The catheter body was found to be accordioned at a couple location.No damages were found with the distal tip.The catheter was measured and found to be within specification.The catheter was dissected, and the ped2 delivery system was removed.The catheter could not be used for testing with an in-house guidewire due to its damaged condition.The ped2 pushwire was found to be bent at the proximal end.The ped2 device was found separated into two segments.The distal hypotube was found to be stretched and ptfe shrink tubing was found to be intact.The pusher was found detached at the distal hypotube weld (solder joint).The proximal bumper and re-sheathing marker were found intact.The re-sheathing pad was found to be missing.Distal and proximal ends of braid were found to be collapsed.The dps restraints/sleeves appear to be in good condition.The tip coil was found intact.The detached pushwire was sent out for scanning electron micrographic (sem) / energy dispersive spectroscopy (eds) elemental analysis.The elemental analysis of the detached pushwire end shows elevated chlorine (cl), iron (fe), silver (ag), tin (sn), chromium (cr), and oxygen (o) peaks were detected on the wire surface, and it is not possible to determine the failure mechanism of the subject wire.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿pipeline damaged during delivery/retrieval¿ was confirmed as the ped2 device was found to be separated at distal hypotube.However, the root cause could not be determined.Regarding the solder joint separation issue, as the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process.Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that severe friction and difficulty occurred during advancement and placement of the pipeline flex with shield (ped2).The ped2 was not placed in the intended location as it missed the landing zone.Resistance was felt within the distal section of the marksman which caused damage to the ped2.This event occurred during the treatment of an aneurysm located in the communicating anterior area.The aneurysm was unruptured, saccular, with a max diameter of 12 and a neck width or 8mm.The distal landing zone was 1.9mm and the proximal was 2.1mm.The vessel anatomy was moderate in tortuosity.No patient injury occurred.The devices were prepared and used per the instructions for use (ifu).The catheter was flushed as per the ifu.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10067914
• MDR Text Key: 207351095
• Report Number: 2029214-2020-00465
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: PED2-250-20
• Device Lot Number: A575709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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: 63 YR