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	Foreign Body In Patient (2687); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant date and concomitant medical products: estimated dates.The device was not returned for analysis.The lot history review and lot specific similar complaint review were not performed because the patient was the only source of information regarding the previous procedures, and the patient did not know the part or lot numbers.Based on the available information, the incomplete coaptation appears to be due to procedural conditions.A cause for the reported foreign body in patient could not be determined.The reported mr appears to be a cascading event of the incomplete coaptation.Additionally, mr is listed in the mitraclip g4 system instructions for use (ifu) as a known possible complication associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention (additional mitraclip procedure) were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
This is being filed to report the clip detaching from one leaflet and increased mr requiring intervention.It was reported that the initial mitraclip procedure was performed in 2018 and 2019, to treat functional mitral regurgitation (mr).Three clips were implanted.The patient returned on a later date with the mr increased to 4+.It was noted the nt clip implanted on the medial side of a2p2 had detached from the posterior leaflet (single leaflet device attachment (slda)).The other two previously implanted clips remained stable on the leaflets.A second procedure was performed on (b)(6) 2021.Two clips were implanted to stabilize the slda clip, reducing mr to 1-2.Per the physician, it appeared the slda clip had grasped chords when implanted.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 12578770
• Report Number: 2024168-2021-08925
• Device Sequence Number: 3322943
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 10/05/2021

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 Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/05/2021
• 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: 69 YR
• Patient Weight: 131