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

Model Number PED2-475-20

Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline stent which failed to open at the distal end during a procedure and then became stuck in the marksman catheter. The patient was being treated for an unruptured fusiform aneurysm of the left interior carotid artery. Dual antiplatelet treatment (dapt) was administered and pru level was 175. Patient vessel tortuosity was normal. It was reported that the catheter was navigated to the desired location. The physician started to deploy the pipeline but the distal end of the stent failed to open properly. The physician made multiple attempts to get the pipeline to open - resheathing and redeploying, removing tension in the system, but all without success. More than 50% of the stent was deployed when it failed to open. The device was resheathed less than or equal to 2 times. It was not positioned in a bend. While trying to resheath the pipeline, it beame stuck in the distal end of the marksman microcatheter. After this occurrence, the pipeline and marksman were removed together from the patient. Both devices were replaced and the procedure was then able to be completed successfully. All devices had been prepared and the catheter flushed per the instructions for use (ifu). There was no harm or injury to the patient. Post-procedure angiographic results were normal.

Manufacturer Narrative

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.

Event Description

Additional information received indicated the pipeline became stuck inside the lumen of the marksman microcatheter. The pushwire was separated from the pipeline, and the distal portion of the marksman catheter was stretched.

• 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
• MDR Report Key: 10824098
• Report Number: 2029214-2020-01118
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2022
• Device Model Number: PED2-475-20
• Device Catalogue Number: PED2-475-20
• Device Lot Number: A907491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 63 YR
• Patient Weight: 74