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

Model Number PED2-500-35

Device Problems Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex embolization device and phenom 27 catheter were returned for analysis.The pipeline flex embolization device was returned within the phenom 27 catheter.The pipeline flex embolization device was removed from within the phenom 27 catheter without issue.The pipeline flex distal hypotube was found bent and stretched with the ptfe shrink tubing pulled back from the proximal bumper.The pipeline flex resheathing pad and marker were found in good condition.The pipeline flex pusher ptfe sleeves were found damaged.The pipeline flex tip coil was found to be in good condition.The pipeline flex braid was not returned as it remains within the patient.The phenom 27 catheter was then examined.The phenom 27 catheter total length was measured to be 157.0cm and the useable length was measured to be 150.5cm.No damage was found with the phenom 27 catheter hub.The phenom 27 catheter body was found accordioned from 10.0cm to 5.0cm from the distal tip.The phenom 27 distal tip was found damaged (indented).No other anomalies w ere observed.Based on the device analysis and reported information, the customer¿s reports of ¿delivery system stuck during retraction¿ and ¿pipeline damaged during delivery/retrieval¿ were confirmed as the pipeline flex pusher ptfe sleeves and phenom 27 distal tip were found damaged.However, the cause for the resistance could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding resistance during retrieval of a pipeline delivery system with a damaged ptfe sleeve through a phenom-27 microcatheter.The patient was treated for an unruptured c4-c5 saccular aneurysm.The aneurysm max diameter was 11mm and the neck diameter was 11mm.Vessel tortuosity was minimal.Dual antiplatelet treatment (dapt) was administered.It was reported that the pipeline was prepared according to the instructions for use.After the pipeline was successfully implanted, the pushwire could not be pulled back into the phenom-27 microcatheter.The devices were removed without further issue or action.It was noted that the pipeline protective sleeve was bent, preventing the retrieval through the catheter.There was no harm or injury to the patient.Post-operative angiography revealed no problem.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11449230
• MDR Text Key: 238836686
• Report Number: 2029214-2021-00276
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2021

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: 06/19/2023
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B043140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2020
• 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