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

Catalog Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	08/21/2019
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.B3 and d11: estimated date.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
This is filed for single leaflet device.It was reported that the initial mitraclip procedure was performed on (b)(6) 2017, to treat degenerative mitral regurgitation (mr) with a grade of 4.Two mitraclips were implanted, reducing mr to 1.On an unknown date, a single leaflet device attachment (slda) was noted.The clip detached from the posterior leaflet and remained attached to the anterior leaflet.On (b)(6) 2019, a second mitraclip procedure was performed to stabilize the slda.Prior to grasping, a posterior prolapse was noted.One clip was implanted, reducing mr from 4 to 1.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the patient anatomy contributed to the reported slda.The reported patient effect of worsening mitral regurgitation (mr) as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The increased mitral regurgitation (mr) is likely due to the reported slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• 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: 8983308
• Report Number: 2024168-2019-11642
• Device Sequence Number: 13530904
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 09/23/2019

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: 03/06/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70306U1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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 IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR