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

Model Number	PED-400-16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description.The pipeline flex appeared to be separated at proximal to the dps sleeves.This condition was not reported at time of the event.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact and fully opened with no signs of damage.Dried blood observed on the sleeves.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex braid were fully opened and no damage.Bends found from the broken end; and from proximal end of the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The broken end sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) analyses.Based on the analysis findings and sem (scanning electron micrographic) / eds (energy dispersive spectroscopy), the fracture surface exhibits dimple features consistent with torsional overload failure mechanism.From the damages seen on pushwire (bending) 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 catheter against resistance.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that pipeline flex device stuck in the phenom catheter.The patient underwent embolization treatment for an unruptured saccular internal carotid artery (ica) para ophthalmic aneurysm with pipeline treatment.Landing zone distal 3.20mm proximal 3.80mm.The vessel was observed moderately tortuous.It was reported that pre images were taken and the pipeline size was chosen.As the pipeline was being seated into the rotating hemostasis valve (rhv) and the pipeline was attempted to advance, immediately the staff felt resistance.The rhv was checked and nothing seemed to be awry.They tried to pull back and the pipeline would not retract.At this point in time, it was felt the device was not safe to continue to put in the body, so requested to have it removed from the patient along with the phenom that it was stuck in.The pipeline never made it out of the phenom catheter into the patient.It never caused harm during the case, it just delayed the procedure.I did notice it appeared something was stuck in the end of the phenom upon removal from the patient, so i have included both the pipeline and the catheter.The physician feels the resistance began as the pipeline entered the hub of the phenom.No patient injury was reported as a result of the event.Evaluation of the returned device found that the pipeline flex appeared to be separated at proximal to the dps sleeves.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9629064
• Report Number: 2029214-2020-00072
• Device Sequence Number: 18927365
• Product Code: OUT
• UDI-Device Identifier: 00847536015876
• UDI-Public: 00847536015876
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: PED-400-16
• Device Lot Number: A834386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR