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

Model Number CDS0601-XTR

Device Problem Difficult to Flush (1251)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

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 Description

This will be filed to report during use of the clip delivery system, the flushing drips stopped suddenly.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.The clip delivery system (cds) was advanced through the steerable guide catheter (sgc) and when the clip was entering into the left atrium (la), the flushing drips from the iv saline solution bag stopped suddenly.The physician retracted the cds into the sgc.The dripping started to flush again, and the physician retried straddling the cds at the same time checking the drips.The dripping stopped again for a moment, but after adding some m knob with the clip inside the la, the dripping restarted to work normally, and the procedure continued without any further issue.One clip was implanted, reducing mr to 1+.There was no adverse patient effect and no clinically significant delay in the procedure.One day after the procedure, the patient presented an excellent clinical outcome without any complications.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have influenced the reported issue.Additionally, a review of the complaint history did not identify any similar incidents.All available information was investigated and without the complaint device to analyze, a cause for the reported difficult to flush cannot be determined in this incident.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report filing, additional information received reported that the patient died on (b)(6) 2021, the clips remained stable and well seated on the leaflets.The physician confirmed, there was no relationship between the patient's heart failure, death and the clips implanted.No additional information was provided.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12094981
• MDR Text Key: 261298605
• Report Number: 2024168-2021-05601
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2021
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 00718U150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 67 YR