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 Hemorrhage/Bleeding (1888); Ischemia (1942); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The additional patient effect of death and malfunctions reported in the article are captured under separate medwatch report(s).Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: article titled "randomized comparison of transcatheter edge-to-edge repair for degenerative mitral regurgitation in prohibitive surgical risk patients.".

Event Description

The clasp iid controlled/randomized trial (b)(4) is the first to evaluate the safety and effectiveness of the pascal system compared to the mitraclip system in patients with significant symptomatic degenerative mitral regurgitation (dmr).In this report, presents the primary safety and effectiveness endpoints for the trial.For the mitraclip group, the major adverse event (mae) rate was 4.8% (3/63) comprising 1 (1.6%) cardiovascular death and 2 (3.2%) severe bleeding.The cardiovascular death (device related) occurred after irrecoverable entrapment of a second mitraclip device in the subvalvular chordal apparatus resulting in 4+ residual mr and patient death.Leaflet perforation was rare, one with the mitraclip implant.There were 2 bleeding events: right humerus fracture from a post-procedure fall requiring surgery with subsequent severe bleeding (possibly procedure related); gastrointestinal bleeding secondary to dual antiplatelet therapy (possibly device related, probably procedure related).Of the 3 additional cardiovascular mortalities in the mitraclip group between 30 days and 6 months, 1 was device related due to mitral stenosis requiring cardiac surgery that led to mesenteric ischemia.Though there were no significant differences in the all-cause mortality and increased heart failure hospitalization (hfh) rates between the two treatment groups, the cardiovascular mortality rate was significantly higher in the mitraclip group at 6 months.At discharge, 100% of patients achieved mr =2+ in both groups.At 6 months, the proportion of patients with mr =2+ was 97.7% in the pascal group and 98.1% in the mitraclip group.At the clasp iid trial demonstrated safety and effectiveness of the pascal system and met non-inferiority endpoints, expanding transcatheter treatment options for prohibitive surgical risk patients with significant symptomatic dmr.Details are listed in the attached article titled, "randomized comparison of transcatheter edge-to-edge repair for degenerative mitral regurgitation in prohibitive surgical risk patients.".

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 this event.Based on the information reviewed and due to the limited information available from the article, the cause of the reported entrapment, death, ischemia, hemorrhage, tissue injury, mitral stenosis, and heart failure were unable to be determined.The recurrent mr appears to be related to the entrapment.The reported patient effects of ischemia, recurrent mr, hemorrhage, tissue injury, mitral stenosis, heart failure, and death, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention, hospitalization, and surgical intervention were the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effect of death and malfunctions reported in the article are captured under separate medwatch report(s)na.

• 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: 15658206
• MDR Text Key: 302335537
• Report Number: 2135147-2022-01750
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: 09/29/2022
• Initial Date FDA Received: 10/24/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 12/08/2022
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male