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

Model Number	PED-400-14
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex (model: ped-400-14 lot: a990043), phenom-027 catheter (model: fg15150-0615-1s lot: de19-027) and phenom plus catheter (model: fg19120-1030-1s lot: au19-037) were returned for analysis.The pipeline flex was found within the phenom-027 catheter.The phenom-027 micro catheter total length was measured to be ~157.1cm, the usable length was measured to be ~150.7cm and the distal single coil length was measured to be ~30.4cm which is within specification (specification: total (reference): 156.5cm, usable length: 150cm ± 5cm, distal single coil length: 30cm ± 2cm).No flash or voids molded were found within the catheter hub; however, dried contrast was found within the hub.No damages or anomalies were found with the hub.The phenom-027 micro catheter body was found accordioned between ~6.7cm and ~10.2cm from the proximal end and found flattened between ~20.8cm and ~1.8cm from the distal end.No damages or irregularities were found with the distal tip or marker band.The micro catheter was flushed with water and water did not exit from the catheter tip.The pipeline flex pusher coil tip was found partially deployed out of the distal end of the catheter and the proximal pusher was found protruding out of the hub ~43.5cm.The pipeline flex was found stuck within the phenom-027 and could not be retracted or advanced out of the catheter.The catheter was cut in order to remove the pipeline flex.The inner diameter was measured to be 0.027¿ (distal) and 0.0265¿ (proximal) which is within specification and compatible for use with the pipeline flex.The phenom-027 could not be tested for resistance with an in-house mandrel or pipeline device as it was destroyed during the extraction.The pipeline flex pusher distal wire was found bent at the re-sheathing pad.The distal and proximal dps restraints were found to be intact.The dps sleeves were found entangled.The hypotube was intact and unstretched and ptfe shrink tubing was still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found intact.Once removed from the micro catheter, the distal and proximal ends of the pipeline flex shield braid were found fully opened, with the proximal end damaged/frayed and the distal end found slightly frayed.The phenom plus micro catheter total length was measured to be ~128.4cm, the usable length was measured to be ~122.2cm and the distal single coil length was measured to be ~30.6cm which is within specification (specification: total (reference): 126.5cm, usable length: 120cm ± 5cm, distal single coil length: 30cm ± 2cm).No flash or voids molded were found within the catheter hub.No damages or anomalies were found with the hub.The phenom plus micro catheter body was found flattened at ~30.2cm, ~71.2cm and between ~24.6cm and ~1.8cm from the distal end.No damages or irregularities were found with the marker band.The distal tip was found slightly crushed.The micro catheter was flushed with water and water exited from the catheter tip.The inner diameter was measured to be 0.0435¿ (distal) and 0.0044¿ (proximal) which is within specification and compatible for use with the phenom-027.No other anomalies were observed.Based on the analysis findings, the customer report of inner liner damage at the distal section could not be confirmed.The customer report of ¿catheter stretch during removal¿ for both the phenom-027 and phenom plus could not be confirmed as no stretching was observed.Both devices were found flattened and the phenom-027 was found accordioned.Possible cause of the flattening are patient vessel tortuosity or user operational context if user advances or retrieves intraluminal device against resistance.Possible causes for catheter accordioning are device removed aggressively or catheter entrapment.The pipeline flex and phenom-027 were confirmed to have ¿resistance during re-sheathing¿ and ¿catheter resistance¿ as the returned pipeline flex was found stuck within the distal segment of the phenom-027 catheter.The likely causes of the resistance are the entangled dps sleeves and the flattened distal section of the phenom-027.The dried contrast found within the catheter likely contributed towards the resistance during in-house testing.The braid was found damaged and frayed, however, it is likely these damages occurred during the removal from the phenom-027.It was reported the pipeline was used for an indication that is not approved: left ica wide neck aneurysm.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the pipeline experienced resistance during resheathing, and the phenom 27 stretched and the inner liner separated.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the left internal carotid artery (ica) with a max diameter of 7mm and a 4mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was reported the pipeline was used for an indication that is not approved: left ica wide neck aneurysm.It was reported that the triaxial support technique was used with the cook shuttle placed in the mid cervical, the phenom plus intermediate in the left ica at the petrous segment, and then the phenom 27 placed at the proximal left middle cerebral artery.The pipeline was then delivered and met heavy resistance upon resheath after pipeline placement came back proximal to the aneurysm.Upon removing the phenom 27 through the phenom plus, it showed signed of stretching.It was reported the catheter was flushed per the instructions for use (ifu), and there was inner liner separation of the catheter in the distal segment.During removal, there was no force applied, the catheter tip was not entrapped/stuck, there was no vasospasm, and the phenom 27 was not stuck in the guide catheter.Once everything was removed, new devices were used to complete the procedure.It was indicated that all devices were prepared as per the ifu, and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed successful implant of the pipeline across the left ica aneurysm.

• 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: 10788067
• Report Number: 2029214-2020-01097
• Device Sequence Number: 14385891
• Product Code: OUT
• UDI-Device Identifier: 00847536015845
• UDI-Public: 00847536015845
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100018
• 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): 11/04/2020

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: 03/10/2023
• Device Model Number: PED-400-14
• Device Catalogue Number: PED-400-14
• Device Lot Number: A990043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 83