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

Model Number PED-475-18

Device Problem Activation Failure (3270)

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

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline embolization device (ped) that failed to open.The patient was being treated for an unruptured saccular aneurysm of the left ophthalmic artery.The aneurysm max diameter was 5mm and the neck diameter was 4mm.The distal landing zone was 3.4mm and the proximal landing zone was 3.7mm.Patient vessel tortuosity was normal.Dual anti-platelet treatment (dapt) was administered.Pru level was normal.It was reported that the ped was delivered and started to deploy but the tip would not open.The ped was adjusted repeatedly but it still failed to open.The surgeon withdrew the ped from the patient's body and replaced with a new ped to successfully complete the procedure.The device had been prepared per the instructions for use (ifu).There was no harm or injury to the patient.

Event Description

Additional information received reported that the distal section of the pipeline did not open.The device had not been placed in a bend at the time, and no resheathing attempts or other steps were taken to open it.

Manufacturer Narrative

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

Manufacturer Narrative

H3: the pipeline flex was returned stuck within the distal segment of the phenom 27 catheter.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 frayed.Bends were found at 16.0cm to 33.5cm from the proximal end.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 12.0cm to 26.0cm 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 device, the pipeline flex was not confirmed to have failure to open at the distal end.The root cause could not be determined as the distal and proximal ends of the pipeline flex braid were found fully opened and frayed.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.It is possible that the patient tortuous anatomy may have contributed to the failure to open issue.In addition, the pipeline flex also found to be stuck inside the distal segment of the phenom 27 catheter.From the damages seen on the catheter (accordioning), pusher (bending), 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.Possible causes of the resistance during delivery include patient's vessel tortuosity and lack of continuous flush with heparinized saline during procedure.There was no non-conformance to specifications identified that led to the failure to open issue.Per our instructions for use (ifu), the user should: ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.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.¿ 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: 10787990
• MDR Text Key: 214754820
• Report Number: 2029214-2020-01096
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536015906
• UDI-Public: 00847536015906
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2021

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: 08/25/2023
• Device Model Number: PED-475-18
• Device Catalogue Number: PED-475-18
• Device Lot Number: B075919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/05/2020; 01/14/2021
• Supplement Dates FDA Received: 11/18/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR