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 Codes	Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
This is being filed to report the single leaflet device attachment (slda), tissue damage and recurrent mr.It was reported that the initial mitraclip procedure was performed on (b)(6) 2017 treat mitral regurgitation (mr) with a grade of 4.One clip (cds0501, 70914u131) was implanted, reducing the mr to <1.On (b)(6) 2019, the patient presented with dyspnea.A control echocardiogram was performed, which found that the most lateral clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).A rupture chord was noted causing severe mr.There was notable leaflet thickening and calcification throughout his heart.There was no treatment performed or planned for the patient.No additional information was provided.
Additional Manufacturer Narrative
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.The device was not returned for evaluation.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 identified no indication of a lot specific product issue.All available information was investigated, and a cause for the reported tissue damage, single leaflet device attachment (slda) and subsequent patient effects could not be determined.The hospitalization was due to case circumstances.The reported patient effects of tissue damage, recurrent mitral regurgitation (mr) and dyspnea, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product quality 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: 9181226
• Report Number: 2024168-2019-12547
• Device Sequence Number: 2774816
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/25/2019

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: 09/15/2018
• Device Catalogue Number: CDS0501
• Device Lot Number: 70914U131
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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
• Patient Age: 79 YR