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

Model Number	CDS0501
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no lot specific product issue at this time.The reported patient effect of recurrent mr as listed in the mitraclip system instructions for use, is a known possible complications associated with mitraclip procedures.All available information was investigated and a definitive cause for the reported clip migration could not be determined.The reported recurrent mitral regurgitation (mr) was due to the clip migration.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report partial clip movement it was reported that the first mitraclip procedure was performed on (b)(6) 2017 to treat grade 4 degenerative mitral regurgitation (mr).Two clips were implanted successfully reducing mr to 1.On (b)(6) 2020, echocardiogram was performed, it was observed that one of the clips had partially moved and mr increased to 4.There was no leaflet injury.A second procedure was performed on (b)(6) 2020, three xtr clips were implanted without issues, reducing mr to 1+.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9758364
• Report Number: 2024168-2020-01802
• Device Sequence Number: 618235
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: 03/30/2018
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 70329U205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 77