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

Model Number PED2-500-35

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

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

Event Date 09/15/2021

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 a pipeline experienced resistance in a phenom 27 microcatheter and the proximal part of the pushwire broke. A non-medtronic guidewire also experienced resistance. The patient was undergoing treatment for a basilar fusiform aneurysm. The patient's vessel tortuosity was severe. The access vessel was the femoral artery, which was 4mm in diameter. It was reported that a merit flexor short touhy was used in this case, and the pipeline got stuck in the touhy. They tried to pull the pipeline out, and got the implant out of touhy/phenom 27 catheter hub. Then, a synchro guidewire would not advance through the phenom 27. The 15mm distal of the pipeline pusher wire tip and polyurethane flaps broke off in the phenom 27. It was believed that this was caused by the touhy. The catheter was removed. They tried to advance a wire through the phenom but could not because the pipeline wire tip remained in the catheter. The phenom was cut open and it was confirmed the wire was in the device. A new phenom catheter was used, but they kept the same short touhy and were met with resistance in advancing the pipeline again. They were able to save this pipeline and changed to a normal touhy, and all went fine thereafter.  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 phenom plus guide catheter.

• 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: 12516673
• MDR Text Key: 272911694
• Report Number: 2029214-2021-01191
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

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

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B245482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/17/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial