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

Model Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Tissue Damage (2104)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This is filed to report the suspected leaflet tear and single leaflet device attachment/slda.It was reported that the initial mitraclip procedure was performed on (b)(6) 2018 to treat grade 4 degenerative mitral regurgitation (mr).Two clips were implanted, reducing mr to grade 1.On (b)(6) 2020, the patient returned for a follow up visit and echocardiogram was performed.Mr increased to 4.It was suspected that there was a minor leaflet tear and one of the clips detached from the anterior leaflet and remained attached to the posterior leaflet (slda).Part of the clip had already endothelialized; therefore, it could not be confirmed if the recurrent mr and leaflet tear were due to disease progression or due to the suspected leaflet tear and slda.A second mitraclip procedure was attempted on (b)(6) 2020; however, during placement of the clip, the gradient increased up to 7mmhg and mr reduction was minor; therefore, the clip was not implanted and the gradient returned to 4mmhg.The procedure was discontinued.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.Additionally, a review of the complaint history identified no similar complaints for the reported lot.The reported patient effects of tissue damage and mitral regurgitation (mr) as listed in the mitraclip ntr/xtr, instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a cause for the reported single leaflet device attachment/slda could not be determined.A cause for the reported mr and tissue damage could not be determined as well.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10712359
• Report Number: 2024168-2020-08784
• Device Sequence Number: 3845404
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 12/07/2020

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: 01/09/2019
• Device Model Number: CDS0501
• Device Catalogue Number: CDS0501
• Device Lot Number: 80108U248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 12/07/2020
• 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 MITRACLIP(X1); IMPLANTED MITRACLIP(X1)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 83