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

Model Number	CDS0501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Tissue Damage (2104)
Date of Event	03/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other additional mitraclip is being filed under a separate medwatch report number.
Event or Problem Description
This is filed to report post mitraclip procedure, the patient returned with increased mr, and leaflet tear requiring medical intervention.It was reported that the index mitraclip procedure was performed on 04/27/2018 to treat mitral regurgitation with grade 4.Two clips (80224u114, 80224u115) were implanted reducing mr to 1.On (b)(6) 2020, the patient returned with significant mr increase of grade 4 and a leaflet tear was noted.A clip (91204u114) was implanted, but gradient went up to 6 mmhg and mr was not reduced.Two vascular plugs were used to successfully complete the procedure, reducing mr to 2.The patient is fine and there was 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.The investigation determined the reported mitral regurgitation appears to be related to the tissue damage.However, a conclusive cause for the tissue damage cannot be determined.The reported patient effects of tissue damage and mitral regurgitation as listed in the ifu are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 9872060
• Report Number: 2024168-2020-02787
• Device Sequence Number: 2952451
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2019
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 80224U115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/10/2020
• 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: 1 ADDITIONAL IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention