MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-400-18

Device Problems Deformation Due to Compressive Stress (2889); Positioning Problem (3009); Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the marksman catheter was deployed until the m1, after which they then delivered and started to open the pipeline at the m1 segment.At this point the most distal part of the pipeline didn't open so they resheathed the device.They then made another attempt during which the device opened with the system pulled until the ica, where the pipeline fell down into the aneurysm neck.The physician tried to resheath and reposition the device but was unable to, so they advanced the navien catheter near the to the proximal of the aneurysm and pulled the marksman and pipeline together into the navien and removed them from the patient.The marksman was checked afterwards which showed that it had deformed like an accordion, with distal stretch damage during removal noted.The case was continued with a new marksman and pipeline with the surgery finishing smoothly.The patient was undergoing surgery to treat an unruptured aneurysm at the left ica with a max diameter of 3.25 x 3.55 mm and a neck diameter of 2.42 mm.The landing zone artery size was 3.85 mm distal and 4.08 mm proximal, with a severe vessel tortuosity noted.The catheter was confirmed to be flushed continuously with herapanized saline and dual antiplatelet treatment was administered with a pru level of 129.The catheter tip was not entrapped or stuck and the angiographic result post procedure was normal.There were no related patient symptoms.

Manufacturer Narrative

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

Event Description

Additional information received clarified that when the pipeline fell down during opening maneuvers the physician tried to re-sheath and move it a little but forward, but the re-sheathing caused the catheter accordion.It was also clarified that during opening maneuvers the system moved down and the distal tip of the pipeline moved to the aneurysm neck which is why the physician attempted to re-sheath and move forward, causing the pipeline falling into the aneurysm neck/inability to deploy.

Manufacturer Narrative

The pipeline flex with shield stuck within the distal segment of the marksman catheter was returned for evaluation; within its inner pouch and a bio-hazard bag; inside of a shipping box.For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty.A minimal amount of blood was observed inside the catheter lumen.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured to be within specifications (od = ~0.5836mm).The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.Kinks and bends were found on the pushwire at 18.5 cm to 29.5 cm from the proximal end.The distal and proximal ends of the pipeline flex shield braid fully opened and moderately frayed.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and the marker band were examined and no damages were found.The catheter body was found to be flattened at 5.0 cm to 10.5 cm; and accordioned at 19.5 cm to 30.5 cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was flushed with water and found to be patent.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the damaged locations.No other anomalies were observed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7756677
• MDR Text Key: 116860868
• Report Number: 2029214-2018-00698
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: A434460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 63