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

Catalog Number	CDS0201
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Stenosis (1965)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 the reported patient effects.The reported patient effects of dyspnea and mitral stenosis, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of worsening mr appears to be related to patient morphology/pathology (disease progression).In addition, the reported mitral stenosis was likely due to patient/procedural conditions, the implanted clip and disease progression.The reported dyspnea was likely a symptom/secondary effect of the mr and mitral stenosis.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 mitral stenosis.It was reported that the initial mitraclip procedure was performed on (b)(6) 2016, to treat degenerative mitral regurgitation (mr) with a grade of 4.Two clips were implanted, reducing mr to 1.After the initial procedure, the pressure gradient was 7mmhg; however, the physician did not consider this mitral stenosis.One day post-procedure, the physician confirmed that the patient was stable.On (b)(6) 2017, the patient returned with dyspnea.Echocardiogram was performed and the mean pressure gradient had increased to 9mmhg, which the physician now considered mitral stenosis.The implanted clips were confirmed to be stable on the leaflets, and the mr had increased to 2 due to progression of disease.The patient was treated with medication, and is currently stable.No further treatment will be performed.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: 6916357
• Report Number: 2024168-2017-07983
• Device Sequence Number: 13783951
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: CDS0201
• Device Lot Number: 51012U113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/05/2017
• 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 ADDITIONAL IMPLANTED MITRACLIP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 120