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

Model Number PED-375-35

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

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

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6). If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline experienced resistance and the tip of the wire was broken. It was reported that after hydration the pipeline could not be transported to the microcatheter. After several attempts, it was found that the developing guide wire at the tip of the stent was broken. The pipeline was replaced, and the surgery was successfully completed. The patient did not experience any injury or complications. Dual antiplatelet treatment was administered, and the patient¿s pru level was normal. The devices were prepared according to the instructions for use (ifu). The patient was undergoing treatment for an unruptured, fusiform aneurysm located in the right internal cervical artery. The max diameter was 15 mm. The neck was 5 mm. The artery landing zone was 3 mm distal and 3. 5 mm proximal. The vessel tortuosity was normal.

• Brand Name: PIPELINE FLEX
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10469072
• MDR Text Key: 209596481
• Report Number: 2029214-2020-00859
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-375-35
• Device Catalogue Number: PED-375-35
• Device Lot Number: A887314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial