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 Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270)

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

Event Date 01/13/2021

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 the pipeline failed to open in the distal section and moved during deployment.The patient was undergoing treatment for an unruptured, fusiform vertebral aneurysm.The landing zone was 3.5mm distal and 4.5mm pro ximal.The patient¿s vessel tortuosity was normal.Dual antiplatelet treatment was administered at a usual pru level.It was reported that the physician started to deploy pipeline, but it didn¿t open distally.They decided to recapture it above the proximal part of the tip coil.They started to deploy it again with success at the distal part and positioned the distal part above the neck of aneurysm and continued to deploy.However, the pipeline moved down during placement.The physician recaptured it again and re-advance it.They started to deploy again, but the pipeline did not open distally.It was recaptured again, but the distal part was damaged with an image of cone.The pipeline was removed and was not used.The device had not been placed in a bend, and less than 50% had been deployed when it failed to open.The pipeline had been resheathed more than 2 times, and no additional steps were taken to open the device.There had been no friction or difficulty during delivery or positioning.The device had been at the intended location.Only a single pipeline was being used when the movement occurred.The pipeline had not missed the landing zone, and the device jumped during deployment.The pipeline was placed at least 3mm past the aneurysm neck on each side, and no side branches were covered by the device.The tip of the catheter had moved during deployment.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Angiographic results post procedure were said to be good.Ancillary devices include a phenom 27 microcatheter.

• 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: 11197215
• MDR Text Key: 227780288
• Report Number: 2029214-2021-00065
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-35
• Device Catalogue Number: PED2-500-35
• Device Lot Number: B019203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• 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: 70 YR