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

Model Number	CDS0201
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	06/12/2017
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 identified no similar incidents reported from this lot.The reported patient effect of worsening mr, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the slda could not be determined.The reported patient effect of worsening mr appears to be a result of procedural conditions and a secondary effect of the slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other clip delivery system (70224u166) referenced in describe event or problem is filed under a separate medwatch report number.
Event or Problem Description
This is filed to report the single leaflet device attachment (slda) (60808u145).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.One clip (60808u145) was implanted, reducing the mr to 1.On (b)(6) 2017, a follow up echocardiogram was performed, and it was found that the clip detached from the anterior leaflet and remained attached to the posterior leaflet (slda).The mr increased to 4.On (b)(6) 2017, a second procedure was performed for treatment.One clip was implanted.The slda clip was stabilized and the mr was reduced to 3.The second clip (70224u166) was advanced and the leaflets were grasped; however, the mr would increase to 4 while grasping.The decision was made to deploy the clip with the mr of 4.After deployment, the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).It was noted that imaging was difficult during the procedure due to shadowing of the implanted clips.The patient was treated with trans aortic valve replacement, and confirmed to be stable post procedure.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: 6701885
• Report Number: 2024168-2017-05776
• Device Sequence Number: 19000341
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170808(10)60808U145
• 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): 07/11/2017

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: 08/08/2017
• Device Model Number: CDS0201
• Device Catalogue Number: CDS0201
• Device Lot Number: 60808U145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/11/2017
• 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: 84 YR
• Patient Weight: 60