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

Model Number PED2-400-30

Device Problems Positioning Failure (1158); Unintended Ejection (1234); Unintended Movement (3026)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a pipeline stent and phenom catheter that jumped during deployment of the pipeline.The patient was being treated for an unruptured saccular aneurysm of the paraopthalmic artery segment.The aneurysm max diameter was 8mm and the neck diameter was 4mm.The landing zone was 3.77mm at the distal end and 4.1mm at the proximal end.The patient was treated during the same procedure for a 6mm aneurysm of the internal carotid artery cavernous segment.Vessel tortuosity was severe.It was reported that all devices were prepared according to the instructions for use (ifu).When the physician attempted to deploy the pipeline across the paraopthalmic aneurysm, the stent opened distally.The physician proceeded to push the stent out around the tortuous vessel when the catheter and stent jumped.The physician attempted to resheath the pipeline stent but the pushwire came back into the stent indicating the stent had slipped off the resheathing pad.The pipeline did not miss the landing zone and was placed at least 3mm past the aneurysm neck on each side.No side branches were covered.However, the device did not deploy at the intended location.No friction had been felt during delivery and positioning of the stent.A guide catheter and phenom could not advance to perform the corking technique to retrieve the pipeline so a 4.0mm x 20mm balloon catheter was used.There were no patient symptoms or complications related to the event.Post-procedure angiography showed good results.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11219299
• MDR Text Key: 228399191
• Report Number: 2029214-2021-00090
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2023
• Device Model Number: PED2-400-30
• Device Catalogue Number: PED2-400-30
• Device Lot Number: A984419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 01/22/2021
• Date Device Manufactured: 02/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR