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 Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2015

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects reported in the article(s) are captured under a separate medwatch report.Date of death is an estimated date.Article titled "edge-to-edge transcatheter mitral valve repair versus optimal medical treatment in nonresponders to cardiac resynchronization therapy: the mitra-crt trial.".

Event Description

This is filed to report death and serious injuries.This study was a single-center randomized, controlled and open-label trial comparing edge-to-edge transcatheter mitral valve repair (tmvr) with the mitraclip device to optimal medical treatment (omt) in nonresponders to cardiac resynchronization therapy (crt) with dilated cardiomyopathy (dcm) and functional mitral regurgitation (fmr).The study included 31 patients: 15 in the control and 16 in the tmvr group.Regarding the safety end point, no procedure related serious adverse events were observed in the tvmr group.Complications noted during 12 month follow-up included: moderate to severe mr, rehospitalization due to heart failure and death (all-cause and cardiovascular).In conclusion, in patients with dcm and crt who were clinically nonresponders and present fmr >2, ¿edge-to-edge¿ tmvr, as compared with omt was associated with a reduction of the combined end point of cardiovascular death, heart transplantation and chronic heart failure (chf) hospitalizations and a reduction in the number of chf hospitalizations and the need of diuretic treatment escalation at 1 year.Details are listed in the attached article titled, "edge-to-edge transcatheter mitral valve repair versus optimal medical treatment in nonresponders to cardiac resynchronization therapy: the mitra-crt trial.".

Manufacturer Narrative

The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported deaths.Death is listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization was a result of case-specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.The additional patient effects reported in the article(s) are captured under a separate medwatch report.Attachment; article titled "edge-to-edge transcatheter mitral valve repair versus optimal medical treatment in nonresponders to cardiac resynchronization therapy: the mitra-crt trial." a2: mean age a3: majority gender b2 - date of death is an estimated date.B3: date of event was estimated as 01/01/2015 d4: the udi is unknown as the part and lot numbers were not provided d6a: date of implant was estimated as (b)(6) 2015.B3: date of event was corrected to 01/01/2015.

• 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 MEDICAL, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15666674
• MDR Text Key: 302393835
• Report Number: 2135147-2022-01776
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/21/2022
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male