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

Catalog Number	CDS0201
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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.However, the reported patient effect of worsening mr appears to be a result of patient/procedural conditions and due to the slda.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This report is filed for increased mitral regurgitation post-procedure and possible single leaflet clip attachment.It was reported that on (b)(6) 2016, one mitraclip was implanted without reported issue reducing degenerative mitral regurgitation (mr).Patient anatomy was very challenging (rotated heart and esophagus that went to the left).On (b)(6) 2017, an echocardiogram showed mr had increased to grade 4.Clip placement was uncertain.On (b)(6) 2017, a second mitraclip procedure was performed.Due to the challenging anatomy, echocardiogram visualization was difficult.It was observed that the first implanted mitraclip had possibly detached from the anterior leaflet, a single leaflet device attachment (slda); however, visualization was difficult.A second mitraclip was successfully implanted lateral to the first reducing the mr from grade 4 to 2.The procedure was completed and the patient is in stable condition.

• 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: 7004419
• Report Number: 2024168-2017-08720
• Device Sequence Number: 1353497
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2017
• Device Catalogue Number: CDS0201
• Device Lot Number: 60712U272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/06/2017
• 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: 85 YR
• Patient Weight: 71