MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Material Protrusion/Extrusion (2979)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

This is being filed for a device that caused damage to another device.It was reported that on (b)(6) 2022, a patient presented with grade 4 primary mitral regurgitation (mr).An xtw clip was successfully implanted.The steerable guide catheter (sgc) was in the patient when a loss of column and blood was observed.Additional aspiration was needed outside of standard instruction for use (ifu) procedure.The column was still not holding, and it was discovered that the stopcock was cracked on the sgc.The physician quickly removed the sgc along with the clip delivery system (cds), as the xtw was already deployed.The cds was removed without fully retracting the spear (distal mandrel) into the introducer, and potentially lacerated the hemostasis valve of the sgc.The cds was removed and a new sgc was prepped.The procedure was completed with a 2nd clip implanted, reducing the mr to 1-2.There was no adverse patient effect or clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation as the clip was implanted and the clip delivery system (cds) was reportedly discarded.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).The steerable guide catheter (sgc) mentioned in b5 and d10 is being filed under a separate medwatch report number.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information reviewed, the reported device damaged by another device (caused damage) and material protrusion / extrusion (actuator mandrel (distal)) appear to be related to the reported user error (improper or incorrect procedure or method) associated with failure to follow steps / instructions and incorrect removal process.The reported improper or incorrect procedure or method (failure to follow steps / instructions) and improper or incorrect procedure or method (incorrect removal) was due to the user did not retract the mandrel properly in the clip introducer before removing the cds and sgc together.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15142305
• MDR Text Key: 297188276
• Report Number: 2135147-2022-00614
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20124R277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 10/02/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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: STEERABLE GUIDE CATHETER
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG