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

Catalog Number UNK CDS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Failure of Implant (1924); Sepsis (2067); Stenosis (2263); Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2010

Event Type  Death  

Manufacturer Narrative

Age: average age.Sex: majority gender.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects and device malfunction, referenced, are filed under a separate medwatch report number.Article: ¿transcatheter edge-to-edge repair for atrial secondary mitral regurgitation.¿.

Event Description

It was reported through a research article that the mitraclip device may be related to recurrent mitral regurgitation (mr), death, mitral stenosis, insufficient mr reduction, bleeding, sepsis, and single leaflet device attachment (slda) requiring reintervention.The study found that use of the newer generations of mitraclips (ntr/xtr or g4) were associated with the optimal mr reduction in patients with atrial secondary mitral regurgitation (asmr), and the number of implanted clips was likely to be less in the newer generations.In conclusion, transcatheter edge-to-edge repair (teer) achieved a high rate of mr reduction in patients with asmr.Severe left atrial dilation and a low leaflet to annular index (lai) were associated with a low incidence of the mr reduction after teer.Our findings highlight that teer is a safe and feasible option for patients with asmr and may refine device selection for transcatheter mitral valve treatments in this subgroup of smr patients.Details provided in the article titled: "transcatheter edge-to-edge repair for atrial secondary mitral regurgitation.".

Manufacturer Narrative

Subsequent to the previous report, this event was discovered a duplicate of a previously filed e-117809 // (b)(6).The event capture and investigation will remain captured in e-117809 // (b)(6).Please reference (b)(6) medwatch report numbers for the reported event and investigation.2135147-2022-01309-01.2135147-2022-01310-01.2135147-2022-01311-01.2135147-2022-01309-00.2135147-2022-01310-00.2135147-2022-01311-00.No further investigation is required.H6: health effect clinical codes 4582 added.Health effect impact code 1802 removed and replaced with 2199.Medical device problem code 2993 removed and replaced with 3189.

Event Description

Subsequent to the initial report, the additional information was received: this was discovered a duplicate of e-117809 // (b)(6).The initial mdr's were already filed and therefore, a follow-up report is being sent, reporting that a duplicate cn, (b)(6), has already been filed and will capture this event.

• 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: 15580189
• MDR Text Key: 301502669
• Report Number: 2135147-2022-01575
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/07/2022

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: 09/16/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 12/07/2022
• 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: 80 YR
• Patient Sex: Female