MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; VALVE REPAIR

Model Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced is filed under a separate medwatch report number.
Event or Problem Description
This is filed to report single leaflet device attachment/slda, prolonged hospitalization, recurrent mitral regurgitation, and medical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.It was noted that the leaflets were friable.On 03/12/2018, three clips were deployed.However, two clips (80102u218, 71211u267) became detached from the posterior leaflet, but remained attached to the anterior leaflet (single leaflet device attachment/slda).The other clip remains stable on both leaflets.Additional treatment was not performed.Three clips were implanted, reducing mr to 3.Then on (b)(6) 2021, it was reported that this was a second mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The patient presented with dyspnea and angina.The clip delivery system (cds) was advanced to the mitral valve, and one clip was deployed.However, the clip became detached from the anterior leaflet, but remained attached to the posterior leaflet (single leaflet device attachment/slda).Tissue damage was suspected.The physician stated the cause of the slda was due to friable leaflets.Additional treatment was not performed.One clip was implanted, and the mr remained at 4.There were no adverse patient effects and no clinically significant delay in the procedure.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 incidents reported from this lot.Based on the available information, the reported single leaflet device attachment (slda appears to have been a result of challenging patient anatomy.A cause for the reported recurrent mitral regurgitation (mr), angina, and dyspnea could not be determined.The reported patient effects of recurrent mr, angina, and dyspnea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization or prolonged hospitalization and unexpected medical intervention were results of case-specific circumstances.There is no indication, of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11666228
• Report Number: 2024168-2021-03130
• Device Sequence Number: 3097289
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 12/11/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 71211U267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 IMPLANTED MITRACLIPS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85