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

Model Number PED2-450-25

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 04/15/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the physician was able to navigate up to the ica and into the mca with the aristotle 14 wire followed by the phenom 27 microcatheter.The physician exchanged the wire for the device without issue.They were able to successfully unsheath/push the device so that it began to open in the mca.They dragged and dropped the device so that the distal end of the device began to open in the horizontal segment just distal to both para opthalmic aneurysms.The device was opening optimally on the distal end.While coming around the anterior genu the device failed to open.The physician attempted multiple attempts to open the device around the genu but could not get it to open.They continued to deploy the device on the proximal end open just as they finished deploying the device.While trying to recapture the sleeves so that they could post process the device either with a j wire or balloon technique, the microcatheter would not pass the unopened middle portion.At this point it was determined the device was twisted through a series of different angles and images.The sleeves had to be retracted back through the partially opened device and passed the point of torsion.While the sleeves were crossing the twisted portion, they pulled back the device and partially folded the open portion of the device that was just proximal to the twist.The device remained in the patient with proximal and distal ends opened and opposed.The middle portion was twisted shut.The devices were not used off label.The pipeline and accessory devices were not prepared as indicated in the ifu, the sleeves were pre-deployed on the back table prior to the insertion into the microcatheter.There were no patient symptoms or complications associated with the event.The angiographic result post procedure showed the pipeline was deployed, proximal and distal ends opened but twist in middle section.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include: stryker axs infiniti, navien.058 - rfx058-115-08 / lot # b325296, phenom 27 - fg15150-0615-1s / lot # 22 2457547, and aristotle 14 guidewire.

Manufacturer Narrative

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: 14222548
• MDR Text Key: 290459214
• Report Number: 2029214-2022-00729
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284558
• UDI-Public: 00763000284558
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-450-25
• Device Catalogue Number: PED2-450-25
• Device Lot Number: B316921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2022
• Date Device Manufactured: 12/23/2021
• 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: 74 YR
• Patient Sex: Female