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

Model Number PED-450-25

Device Problems 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 09/17/2020

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 first pipeline reached the target location with the marksman microcatheter. However, during the deployment process, the pipeline failed to open in the distal segment. The surgeon followed the instructions, re-sheathed, and redeployed the stent more than twice, then waited for more than 10 minutes each time. The slack in the system was released as well, but the stent still would not open. More than 50% had been deployed, the stent was not in a bend, and no additional steps were taken to open the device. It was also stated the stent became locked up in the distal segment of the marksman even though a continuous flush was used. There was no damage to the pipeline pushwire. The devices were removed from the patient. A new pipeline, and marksman of the same model/lot# were used, but the second pipeline became stuck at the distal end of the marksman during delivery. The slack was released in the system, but the issue did not resolve. The distal segment of the second marksman became accordioned, and there was no damage to the pipeline pushwire. Replacement products were used again, and the procedure was completed without issue. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results showed the blood flow diversion was satisfied. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the cavernous sinus segment with a max diameter of 7. 88 mm and a 5. 18 mm neck diameter. It was noted the patient's vessel tortuosity was moderate.

• 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: 10564460
• MDR Text Key: 207910323
• Report Number: 2029214-2020-00955
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• 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
• Report Date: 12/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: B013806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

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