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	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The devices were not returned for analysis.A review of the complaint history could not be performed as the part and lot was not reported.The reported patient effect of recurrent mitral regurgitation (mr), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated single leaflet device attachement (slda) appears to be related to patient morphology/pathology.The reported patient effect of mitral regurgitation was likely a result of the slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report a single leaflet device attachment (slda) and recurrent mitral regurgitation (mr).It was reported that on (b)(6) 2016, a mitraclip procedure was performed to degenerative mitral regurgitation (mr) with a grade of 4+.Two mitraclip¿s (b)(4) were implanted, reducing mr to a grade of 1+.On (b)(6) 2019, echocardiogram was performed and showed that mr had increased to a grade of 4+.It was suspected that one of the clips had detached from one of the leaflets (single leaflet device attachment/slda).On (b)(6) 2019, a second mitraclip procedure was performed to reduce mr with a grade of 4+.It was confirmed that an slda occurred and the lateral of the two implanted clips had detached from the posterior leaflet and remained attached to the anterior leaflet.Therefore, to stabilize the slda, an additional clip was implanted laterally, reducing mr to a grade of 1+.There was no clinically significant delay in the procedure.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: 9467232
• Report Number: 2024168-2019-14509
• Device Sequence Number: 3103501
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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 Catalogue Number: CDS0501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/13/2019
• 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: IMPLANTED MITRACLIP (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 99