MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number PED-450-25

Device Problem Break (1069)

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

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the distal segment of the pipeline pushwire broke.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right cavernous internal carotid artery with a max diameter of 20mm and a 5mm neck diameter.It was noted the patient's vessel tortuosity was minimal.It was reported that the pipeline was deployed with no issues.Upon retrieving the delivery system, the wire broke about five inches from the distal tip.Per the physician, not much force was delivered.The broken part of the pushwire was inside of the phenom microcatheter enough that it was able to be easily retrieved and removed from the patient.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a benchmark guidecatheter, phenom27 microcatheter.

Event Description

(b)(6) 2020 mpxr 730789 (hcp, rep): medtronic received a report that the distal segment of the pipeline pushwire broke.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right cavernous internal carotid artery with a max diameter of 20mm and a 5mm neck diameter.It was noted the patient's vessel tortuosity was minimal.It was reported that the pipeline was deployed with no issues.Upon retrieving the delivery system, the wire broke about five inches from the distal tip.Per the physician, not much force was delivered.The broken part of the pushwire was inside of the phenom microcatheter enough that it was able to be easily retrieved and removed from the patient.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a benchmark guidecatheter, phenom27 microcatheter.(b)(6) 2020 e1, e2 (rep): no additional information received.2020-07-01 additional information: resistance was felt when the coil was inserted in the catheter hub.It is unknown if the coil did exit the introducer sheath smoothly.

Manufacturer Narrative

The pusher hypotube was found broken near the distal end of the hypotube with the ptfe shrink tubing damaged at that same location.No stretching was found with the hypotube.No damages or irregularities were found with the resheathing marker, resheathing pad, distal marker, delivery wire, proximal bumper and tip coil.No damages or irregularities were found with the rest of the pusher.The broken end of the hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.Sem/eds summary: the fracture surfaces exhibit corrosion damage.The fracture features (dimples) observed indicate an overload type failure mechanism.¿ no other anomalies were found.Based on the analysis findings, the pipeline flex was confirmed to have ¿pushwire break/separation¿.It is possible the customer used high force when advancing the pusher and retracting the catheter against resistance causing the hypotube to break.Customer reported resistance within inserting into the hub and reported not much force was used.The sem testing results confirm an overload type failure.As the micro catheter and braid were not returned for analysis, any contribution of the micro catheter and the braid towards the pushwire break/separation could not be determined.The phenom-027 micro catheter has an inner diameter of 0.027¿ and is therefore compatible for use with the pipeline flex per instruction for use.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PIPELINE FLEX
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10172294
• MDR Text Key: 202072111
• Report Number: 2029214-2020-00567
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016507
• UDI-Public: 00847536016507
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: A852721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Date Manufacturer Received: 07/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1