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

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)

Event Date 10/17/2023

Event Type  Injury  

Event Description

This research article was a retrospective study aimed to compare mitral valve transcatheter edge to edge repair (teer) outcomes of patients who recently had an aortic transcatheter valve replacement (tavr) within six months, versus those who have not had previous tavr within the same calendar year.Complications identified in this study include: death, hospitalization, stroke, kidney injury, and heart failure.In conclusion, both groups had similar in-hospital mortality, although the m-teer after tavr group had a higher rate of 30-day all-cause hospitalizations (ach) and heart failure hospitalization (hfh).Nonetheless, the 90-day hospitalization rate was lower after m-teer compared with before m-teer in patients with previous tavr, driven by a reduction in hfh.Details can be found in the article "mitral valve transcatheter edge-to-edge repair after q1 tavr: a nationwide analysis.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause for the reported patient effects (i.E., death, stroke, kidney injury, heart failure) could not be determined as no case-specific details were provided.The reported patient effects of death, cerebrovascular accident, renal failure, and heart failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18134683
• MDR Text Key: 328083786
• Report Number: 2135147-2023-05010
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other