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

Model Number PED2-375-20

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2020

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 after the first pass, the physician had to cover the pipeline.The positioning was changed, but during the second re-sheathing, the distal segment of the pipeline failed to open.It was noted the pipeline was not positioned in a bend, more than 50% had been deployed, re-sheathing was done less than three times, and no additional steps were taken to open the device.The pipeline was removed from the patient, and a replacement was used to complete the procedure.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.The post-procedure angiography showed okay results.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery.The patient's vessel tortuosity was normal.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was not available.Ancillary devices include an arrow 11 cm sheath, excelsior xt-27 microcatheter, hybrid guidewire, axium coils.

Manufacturer Narrative

Product analysis findings: the pipeline flex with shield stuck inside the non-medtronic microcatheter.The pipeline flex with shield could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex shield from the catheter lumen.A moderate amount of blood was observed inside the catheter lumen.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.When pushing the pipeline flex with shield braid out from the catheter lumen, the braid appeared not opened due to damaged braid and dried blood.The braid was then soaked in the enzyte solution to remove the blood.After soaking for 30 minutes, the distal and proximal ends of the pipeline flex with shield were found fully opened and moderately frayed.In addition, the middle section of the pipeline flex with shield braid appeared fully opened and no damage.The pusher was found to be bent at ~33.0cm and ~38.0cm from proximal end of pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The catheter tip and marker were examined; and no damages were found.The catheter distal tip appeared to be flattened.In addition, the catheter body found to be accordioned at 11.0cm to the catheter hub.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.No other anomalies were observed.Based on the returned device, the pipeline flex shield was confirmed to have failure to open at the distal end as the pipeline flex shield braid due to damaged braid.Dried blood was also observed around the braid.However, after remove the dried blood, the distal and proximal ends of the pipeline flex with shield braid were found fully opened and m oderately frayed.Furthermore, the returned pipeline flex with shield was also found to be stuck inside the catheter.The pipeline flex with shield pushwire and catheter were also found to be damaged.From the damages seen on the catheter body (accordioning/flattening), pusher (bending), pipeline flex with shield braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex with shield through the catheter against resistance.It is possible that the damaged braid may have contributed to the failure to open issue.However, the cause for resistance could not be determined.The customer reported that the patient vessel tortuosity was normal.There was no non-conformance to specification that may have contributed to the failure to open issue.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10542090
• MDR Text Key: 207222136
• Report Number: 2029214-2020-00934
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

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: 06/27/2021
• Device Model Number: PED2-375-20
• Device Catalogue Number: PED2-375-20
• Device Lot Number: A667897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 58