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

Model Number PED-425-25

Device Problem Activation Failure (3270)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not received.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during release of pipeline 4.25 x 25 there was no opening of the distal part and device body.New devices were used to treat the patient.The event occurred when the device was less than 50% deployed.The device was less than or equal to 2 times.The device was removed with the catheter.This event occurred during the treatment of an unruptured, saccular aneurysm in internal carotid left ophthalmic segment.Measuring 14mm and 7mm neck.The distal landing zone was 3.7mm and the proximal was 4.2mm.No patient injury occurred.The devices were prepared per the instructions for use (ifu).

Event Description

A continuous flush was used during the procedure.Vessel tortuosity was described as normal.

Manufacturer Narrative

The pipeline flex could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex from the catheter lumen.A moderate amount of blood was observed inside the catheter lumen.When compared to the drawings 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 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 were found fully opened and moderately frayed.In addition, the middle section of the pipeline flex braid appeared fully opened and no damage.Bends were found at 11.0cm to 32.0cm from the proximal end of the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.When compared to the drawings the total and usable lengths of the catheter were measured to be within specifications.The catheter tip and marker were examined; and no damages were found.The catheter body found to be accordioned at 14.5cm to 30.5cm 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 with no issues; however, the resistance observed at the damaged locations.Based on the customer's photos and returned device, the pipeline flex was confirmed to have failure to open at the distal end 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 braid were found fully opened and moderately frayed.Furthermore, the returned pipeline flex was also found to be stuck inside the marksman catheter.The pipeline flex pushwire and catheter were also found to be damaged.From the damages seen on the catheter body (accordioning), pusher (bending), pipeline flex braid (fraying) and hypotube (stretching); it appears t here was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex 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 and continuous flushed was maintained during delivery.Based on the returned devices, there was no non-conformance to specifications identified that led to the failure to open issue and resistance issues.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: 9379904
• MDR Text Key: 183160634
• Report Number: 2029214-2019-01172
• Device Sequence Number: 1
• Product Code: OUT
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2020
• Device Model Number: PED-425-25
• Device Catalogue Number: PED-425-25
• Device Lot Number: A430986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR