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

Catalog Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incident reported from this lot.The reported patient effect of recurrent mitral regurgitation (mr) as listed in the mitraclip system instructions for use, are a known possible complication associated with mitraclip procedures.All available information was investigated, a definitive cause for the reported slda and poor imaging could not be determined.Additionally, the reported patient effect of mr was due to reported slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed for single leaflet device attachment.It was reported that the initial mitraclip procedure was performed on (b)(6) 2018, to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip was implanted, reducing mr to 1.Imaging was reportedly difficult.The clip remained stable on both leaflets.At the 30-day followup, the patient present with unspecified symptoms.The clip still remained stable on both leaflets.However, the patient presented with symptoms again 3-6 months later but the patient did not want to undergo a second procedure at the time.On an unknown date, a single leaflet device attachment (slda) was noted.The clip detached from the posterior leaflet and remained attached to the anterior leaflet.The mr increased to 4.On (b)(6) 2019, the patient underwent a second mitraclip procedure to stabilize the slda.One clip was implanted, reducing mr to 1.It was reported that imaging was difficult.The patient is stable and doing well.There was no clinically significant delay in the procedure.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: 9323023
• Report Number: 2024168-2019-13578
• Device Sequence Number: 2282322
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 01/24/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80123U247
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/14/2019
• 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: 73 YR
• Patient Weight: 76