MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP NTR CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number	CDS0601-NTR
Medical Device Problem Codes	Incomplete Coaptation (2507); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
This is filed to report unintended movement of the delivery catheter (dc) handle, and a single leaflet device attachment (slda), requiring intervention.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 3+ with an enlarged atrium and a prolapsed anterior leaflet.The first clip (ntr) was advanced to the mitral valve.It was noted that the delivery catheter (dc) handle could rotate while the dc fastener was fastened.The clip was able to be implanted.Few minutes after deployment, the clip had detached from the anterior leaflet (single leaflet device attachment (slda)).Another clip (xtr) was advanced to the mitral valve.Due to slda, the leaflets were not moving synchronously, causing difficulty grasping the leaflets.A loss of leaflet capture was experienced after the grippers were lowered.After about six hours of grasping attempts, the physician concluded that the system was unstable.It was noted that the m-knob did not work as usual; and the delivery catheter (dc) handle could rotate while the dc fastener was fastened.The second clip was removed.It was noted that the ¿+¿ knob on the steerable guide catheter (sgc) had to be turned more than usual to get an ideal curve.One day post-procedure, mr have worsened to grade 4+.It is unclear what have caused the mr to worsen, but it was thought to be tissue damage.No additional information was provided.
Additional 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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, the reported unintended movement (dc shaft positioning) was determined to be a normal function of the device.A cause of the reported incomplete coaptation (slda) could not be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• 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: 17371982
• Report Number: 2135147-2023-03132
• Device Sequence Number: 7145758
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 30327R1075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male