MAUDE Adverse Event Report: CPI - DEL CARIBE INGEVITY; IMPLANTABLE LEAD

Model Number 7740

Device Problems Difficult To Position (1467); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that right atrial (ra) lead was found dislodged as confirmed via x-ray.A revision procedure was performed wherein the physician attempted to reposition the lead, but it exhibited placement difficulties and its helix was unable to be re-extended.The ra lead was extracted and replaced with an alternate.No additional adverse patient effects were reported.

Manufacturer Narrative

This lead was returned to boston scientific¿s post market quality assurance laboratory with the helix mechanism in an extended position.Visual inspection found dried blood/tissue around the helix, which prohibited mechanical movement.Subsequent testing did not identify any product abnormalities that may have caused or contributed to the reported clinical observations.Laboratory analysis was unable to conclusively determine the root cause of the reported observations.The ingevity mri-compatible lead was designed with a goal of balancing multiple design inputs, including implant handling and short and long term safety performance (e.G., low dislodgement and perforation occurrence).The single filar inner coil design of the ingevity lead was selected for improved fatigue durability and for safe performance within an mri environment (protective against lead heating).Physician implant technique and patient anatomy may contribute to helix extension difficulty.Specifically, tortuous patient anatomy or bends in the proximal portion of the lead remaining outside of the body, sharp bends in the stylet, and/or kinks in the lead introducer sheath may contribute to situations where adequate torque is not transferred to the helix to enable extension/retraction.Implant techniques such as under-rotating or over-rotating the terminal tool, failure to remove the terminal tool between extension/retraction cycles to release torque stored in the inner coil, excessively fast tool rotation speed (>1 full turn per second), and the presence of tissue in the helix, which may accumulate with multiple lead repositioning attempts may also contribute to situations where adequate torque is not transferred to the helix to enable extension/retraction.Approved instructions for use provided with all products includes best practices and clear guidance to mitigate these potential contributing factors.

• Brand Name: INGEVITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7497794
• MDR Text Key: 107691007
• Report Number: 2124215-2018-08463
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526523427
• UDI-Public: (01)00802526523427(17)20190809
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2019
• Device Model Number: 7740
• Other Device ID Number: INGEVITY MRI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/10/2018
• Supplement Dates FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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
• Treatment: 0292; 4671; 4674; 7740; G148
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR