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

Model Number PED2-500-30

Device Problems Break (1069); Positioning Failure (1158); Physical Resistance/Sticking (4012)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Physician is not provided based on country privacy laws. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding difficulty with positioning of a pipeline device and failure of the middle segment to open. The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular aneurysm of an internal carotid artery (ica) c3 segment. The aneurysm max diameter was 11. 42mm and theneck diameter was 4. 2mm.  the blood vessel diameter of m1 was about 3mm, and the blood vessel diameter from the internal carotid (ic) top to the ophthalmic artery was about 4mm. Vessel tortuosity was moderate. It was reported that the pipeline flex with shield was prepared according to the instructions for use (ifu). An attempt was made to deploy the ped in the m1 but the deployment was insufficient. As the microcatheter was repeatedly raised and lowered from the sleeve to the middle of the pipeline, the distal end developed a trumpet shape and the middle section did not open at all. It was thought the device was possibly damaged so it was retrieved and replaced with a different lot. However, the replacement pipeline also had difficulties with deployment resistance with the sleeve. It was considered that the pipeline size might not be correct so the device was resheathed to retrieve. During retrieval, the pushwire broke so the device and microcatheter were removed together. Another device was used to complete the event. There was no harm or injury to the patient. Post-operative angiography was normal.

• 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: 12389210
• MDR Text Key: 268998088
• Report Number: 2029214-2021-01089
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018
• 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: 10/28/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/30/2021
• 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: B169702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial