MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number	CDS0201
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Heart Failure (2206)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.All available information was investigated and a definitive cause for the single leaflet device attachment (slda) in this incident could not be determined.The increased mitral regurgitation (mr) is likely due to the reported slda.The reported patient effects of worsening mr and worsening heart failure are listed in the mitraclip system instructions for use (ifu) as 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 filed to report the single leaflet device attachment (slda) and increased mitral regurgitation (mr).It was reported that the initial mitraclip procedure was performed on (b)(6) 2015, to treat degenerative mitral regurgitation (mr) with a grade of 4+.One clip was implanted, reducing mr to 2+.On (b)(6) 2019, the patient was admitted for heart failure.It was found that the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).In the physicians opinion, it is unclear what caused the slda.The mr increased to 3-4+.No treatment is planned at this time as the patient is evaluating options.There was a clinically significant delay in the procedure resulting in prolonged hospitalization for heart failure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number: (b)(4).
Event or Problem Description
Subsequent to the initially filed medwatch report, the following information was received: on (b)(6) 2019, the patient underwent a second mitraclip procedure.An additional clip was implanted without issue, reducing mr from 4+ to 2+.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8700201
• Report Number: 2024168-2019-04701
• Device Sequence Number: 11331462
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 10/31/2016
• Device Catalogue Number: CDS0201
• Device Lot Number: 51026U118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/29/2019
• 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; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 59