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

Model Number PED2-250-12

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/25/2021

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 that had foreshortening.The patient was undergoing a procedure for flow diverter treatment of an unruptured saccular aneurysm of the right middle cerebral artery bifurcation that compromised the m2 branch.The aneurysm max diameter was 6.5mm and the neck diameter was 4mm.Vessel tortuosity was moderate.It was reported the pipeline flex with shield device and all accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline was delivered by the phenom 27 microcatheter beyond the neck of the aneurysm and deployment began properly.Imaging confirmed the distal part of the pipeline stent covered the aneurysm neck well and it opened without complication.The stent delivery system and microcatheter were then recovered and before reaching the sleeves, the stent released and was observed to shorten and no longer cover the neck of the aneurysm. it was noted that the tip of the catheter was moved during deployment.The pipeline was implanted at the intended location with full wall apposition achieved. an additional device was needed to achieve full aneurysm neck coverage.No side branches were covered by the pipeline.There were no other patient symptoms or complications associated with this event.Post-procedure angiographic results showed all the cerebral vasculature was preserved.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12548107
• MDR Text Key: 273835282
• Report Number: 2029214-2021-01219
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P100018.S033
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: PED2-250-12
• Device Catalogue Number: PED2-250-12
• Device Lot Number: B181005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2021
• Date Device Manufactured: 03/25/2021
• 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: 66 YR
• Patient Weight: 65