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

Model Number PED-500-35

Device Problems Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

Refer to manufacturer report 2029214-2021-00184 for details pertaining to the related reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline stent implantation was unsuccessful twice.The first time was because the pipeline delivery guidewire was broken.The second time, the distal was enlarged during the operation and the anchoring was unstable.It was flattening at the bent site and required repeated swinging to release, but the distal fell down during swinging.The case itself was rather difficult, so it failed again.Replacement devices were 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.Post-procedure angiographic results showed normal embolism.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right c4 internal carotid artery (ica) and left c5 ica with a max diameter of 15.54 mm and a 11.63 mm neck diameter.It was noted the patient's vessel tortuosity was minimal.Pipeline lot #: b032587 was used with catheter lot #: nv19-035; pipeline lot #: b118889 was used with catheter lot #: nv19-048.Additional information received clarified the damage to the pushwire, it was stated the wire separated into two sections.When the pipeline was delivered into the microcatheter, the resistance was too large which broke the pushwire.It was clarified with the second pipeline that due to the poor opening of the middle section of the stent in the blood vessel, it was repeatedly recovered and released.This resulted in damage to the pipeline tip and it was unable to open at the head end.There was no resistance encountered with the second pipeline.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was not recorded.Refer to manufacturer report 2029214-2021-00184 for details pertaining to the related reportable event.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the pipeline flex (lot no.B118889) found that the pipeline flex could not be pushed forward or removed.For further examination, the phenom 27 catheter was cut to remove the pipeline flex.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.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.No bend was found with the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the phenom 27 catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 4.0 cm to 14.5 cm from the distal tip.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; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline flex was not confirmed to have ¿failure to open¿ issue as the returned pipeline flex braid was found fully opened with moderately frayed at both ends.The damage to the braid on the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times.Possible causes of failure to open include patient tortuous anatomy and damaged braid.In addition, the pipeline flex was also found stuck inside the distal segment of the phenom catheter.From the damages seen on the catheter (accordioning), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex through the phenom catheter against the resistance.However, the cause for resistance could not be determined.Possible causes of the resistance during delivery include patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure.H6: method code updated to b01.Result code updated to c0702 and c070601.Conclusion code updated to d15.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: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11343746
• MDR Text Key: 232518592
• Report Number: 2029214-2021-00185
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016903
• UDI-Public: 00847536016903
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: PED-500-35
• Device Catalogue Number: PED-500-35
• Device Lot Number: B118889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 65