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

Catalog Number	CDS0201
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 investigation was unable to determine a conclusive cause for the reported clip opened while locked.It is possible that there were procedural interactions (e.G.The patient anatomy and unintended curves on the device) which resulted in increased tension on the clip and leaflets, resulting in the clip opening slightly after deployment; however, this cannot be confirmed.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.
Event or Problem Description
This is filed to report that the clip opened during deployment.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Only one clip was planned as the physician did not want the procedure to be long due to the patient age.The steerable guide catheter (sgc) was advanced, but resistance was met with the septum.The sgc was removed, and the septum was dilated.The sgc was then advanced without issue.The clip delivery system (cds) was advanced to the mitral valve and the leaflets were grasped.During deployment, after the actuator knob was turned 8 times, it appeared that the clip opened to approximately 30 degrees (while locked).The one clip was implanted, reducing the mr to 3+.The patient was confirmed to be stable post procedure, with improved hemodynamics.There were no adverse patient effects and no clinically significant delay in the 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: 6526029
• Report Number: 2024168-2017-03639
• Device Sequence Number: 840408
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914(17)170726(10)60726U109
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2017
• Device Catalogue Number: CDS0201
• Device Lot Number: 60726U109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/27/2017
• 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: MITRACLIP SYSTEM, STEERABLE GUIDE CATHETER
• Patient Weight: 73