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

Model Number PED2-500-18

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problems Headache (1880); Therapeutic Response, Decreased (2271)

Event Date 09/24/2020

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 original pipeline implanted required balloon angioplasty, but the distal end still failed to open.Two additional pipelines failed to open in the distal segments when used as intervention.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery with a max diameter of 4.57 mm and a 7.2 mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown.It was reported that the patient was treated with a ped2-500-18 for a large cavernous carotid aneurysm.The vessel tortuosity was severe with evidence of stenoisis in the distal landing zone of unclear origin.The first pipeline was very difficult to deploy and required post-op angioplasty which improved apposition at the proximal end but only mildly improved apposition at the distal end.Repeated attempts at angioplasty at the distal end were unsuccessful in achieving a fully opened pipeline.The procedure was completed, and the patient was sent to the intensive care unit (icu).The patient then awoke complaining of a headache, and angiography showed further narrowing of the distal end of the pipeline.The plan to deliver a coronary stent was unsuccessful as the vessel was too tortuous to deliver.Further balloon angioplasty was required, and then an attempt to deploy a 5x20 mm pipeline at the distal end was made.The technique used was to unsheath the distal segment and then transition to 80% push on the delivery wire.The distal end appeared to be stuck on the ptfe sleeves, and the doctor tried to resheath the device in order to push the sleeves out of the way.On further attempts at deployment, the distal end still did not open, and it appeared particularly flat on the inferior side.The doctor removed the pipeline through the microcatheter and noticed the distal tip was still closed once the pipeline was on the operating table.Another pipeline (5x10 mm) was then delivered without incident to the tip of the phenom microcatheter, and once again the distal end of the pipeline did not pen.A combination of unsheathing, pushing on the delivery wire, and loading and unloading the system was performed without success.The doctor managed to deliver the microcatheter and pipeline further distally into a straighter segment of the vessel, but this did not result in opening of the distal end.The doctor repeated the same exercises as he did in the proximal segment, but the pipeline still failed to open.The pipeline was removed from the patient.A solitaire ab (6 mm) was delivered and deployed with some improvement in the distal end of the original pipeline.It was noted the pipelines were in a bend: perfectly positioned in a u-shape around the carotid siphon.Post-procedure angiography showed the distal end of the original pipeline was still narrowed, but was improved with the solitaire ab in situ.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.

• 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: 10624695
• MDR Text Key: 209799604
• Report Number: 2029214-2020-00992
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-500-18
• Device Catalogue Number: PED2-500-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• 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: 70 YR