MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Model Number	CDS0201
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A review of the complaint history identified no similar incidents reported form this lot.Based on the available information, a cause for the reported slda could not be determined.The reported mr appears to be a cascading effect of the slda.Additionally, mr is listed in the instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.
Event or Problem Description
This is filed to report slda, increased mr.It was reported that on (b)(6) 2015, the patient was treated for mixed mitral regurgitation (mmr) with 2 mitraclip devices and mr was reduced to 3+.On (b)(6) 2021, the patient had a transesophageal echocardiogram (tee) as the patient was experiencing mr with a grade of 4+.It was found that one clip had a single leaflet device attachment (slda) from the lateral a2p2 leaflet.The clip was stable as there was another implanted right next to it during the index procedure.No additional procedure has been performed.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11227124
• Report Number: 2024168-2021-00593
• Device Sequence Number: 17022273
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: 08717648195914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 05/31/2016
• Device Model Number: CDS0201
• Device Catalogue Number: CDS0201
• Device Lot Number: 50505U155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/25/2021
• 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: IMPLANTED CDS 50409U119
• Outcome Attributed to Adverse Event: Other