MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT

Model Number PED2-500-30

Device Problems Break (1069); Activation, Positioning or SeparationProblem (2906); Activation Failure (3270)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that the tip of the pipeline flex with shield technology did not open after it was deployed, and the distal wire disconnected from the pushwire. Re-sheathing was done more than 3 times to attempt to open and deploy it but without success. The pipeline flex with shield technology was also noted to be shortened. The device was removed with snare / collection equipment and replaced by a medtronic product to complete the procedure. It was reported there were difficulties deploying in the distal region of the pipeline flex with shield technology. The pipeline flex with shield technology was deployed less than 50%. In an attempt to deploy the pipeline flex with shield technology, the physician pushed the device with more strength against resistance. Ancillary devices: chikai 14 guidewire, phenom 27 microcatheter, navien 5fr guide catheter, shuttle 6fr sheath follow up response received with the following information: friction was not noticed during delivery or positioning. The pipeline did not jump. Multiple pipelines were not used. The tip of the microcatheter was not under stress. It was reported that the microcatheter dislodged naturally during deployment. Re-sheathing was performed repeatedly. It was confirmed that the distal wire disconnected, and the distal side was deformed. Follow up response received with information that the catheter dislodged spontaneously (unexpectedly) during deployment.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 10499441
• MDR Text Key: 206124655
• Report Number: 2029214-2020-00901
• 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

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: B002405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial