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

Model Number PED2-500-20

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

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline failed to open, experienced resistance during retrieval, and the pushwire broke. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the paraclinoid segment of the left internal carotid artery. The patient's vessel tortuosity was moderate. The access vessel was the femoral artery, which was 2. 0mm in diameter. The landing zone was 4. 8mm distal and 5. 1mm proximal. It was reported that the pipeline did not open distally even after massaging the device. After trying for several minutes and not su cceeding in opening the device, the doctor decided to remove it. When trying to retrieve the device it became stuck in the proximal hub of the microcatheter. When attempting to retrieve the device, the distal shaft of the delivery system broke. There was no damage to the catheter. A continuous flush had been administered.  no further hospitalization or medical surgical interventions were needed, and the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a sofia catheter and marksman microcatheter.

Manufacturer Narrative

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

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13018381
• MDR Text Key: 287013181
• Report Number: 2029214-2021-01622
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: B044935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial