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

Catalog Number	CDS0201
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Regurgitation (1964)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 identified no other incidents from this lot.Single leaflet device attachment (slda) may be influenced by anatomical morphology of the mitral valve, including tethering of the leaflets, chordae interaction, or leaflets that are thinner/thicker, restricted and prolapsed etc.It is possible that the patient anatomy contributed to the reported slda; however this cannot be confirmed.The reported slda likely resulted in the reported mitral regurgitation and dyspnea.The reported patient effect of worsening mitral regurgitation and dyspnea as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This is being filed to report dyspnea, single leaflet device attachment/slda, recurrent mitral regurgitation, and prolonged hospitalization.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4+.It was noted bi-leaflet prolapse.On (b)(6) 2016, two clips (60525u114, 60525u115) were successfully deployed, reducing mr to 2+ on (b)(6) 2019, the patient was re-admitted for shortness of breath.A transesophageal echocardiography (tee) was performed, and one of the clips (60525u114, 60525u115) became detached from the posterior leaflet, but remained attached to the anterior leaflet (single leaflet device attachment/slda), increasing mr to 4+.The patient is currently hospitalized, and treatment has not yet been performed.The other clip is stable on the leaflets.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: on (b)(6) 2019, the patient was re-admitted to undergo a second mitraclip procedure to treat recurrent mitral regurgitation (mr) with a grade of 4+.An attempt was made to implant an additional mitraclip.The clip delivery system (cds) was advanced to the mitral valve; however, when the clip grasped the leaflets on the medial side, the mean pressure gradient increased to 5mmhg.A decision was made to grasp on the lateral side, and the mean pressure gradient was at 2mmhg.But, there was no mr reduction.The clip delivery system was removed with the clip attached and the procedure was aborted.The other previously implanted clip remains stable on the leaflets.No additional clips were implanted, and mr is 4+.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.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 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 identified no other incidents from this lot.The reported single leaflet device attachment (slda) likely resulted in the reported mitral regurgitation (mr) and dyspnea.The reported patient effects of worsening mitral regurgitation (mr) and dyspnea are listed in the mitraclip system instructions for use 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: 9371875
• Report Number: 2024168-2019-13901
• Device Sequence Number: 14025130
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/20/2019

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: CDS0201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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: ONE IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR