MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0705-XTW

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

Patient Problems Vascular Dissection (3160); Unspecified Tissue Injury (4559)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

B5: the malfunction reported in the article is captured under a separate medwatch report.B3: date of event was estimated.D4: lot numbers were not provided.D6a: date of implant was estimated.Details are listed in the attached article titled, "spontaneous healing of iatrogenic left atrial dissection: a rare complication of mitraclip therapy." 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 is filed to report vascular dissection that required medication as intervention.It was reported that a patient presented with heart failure due to massive atrial functional mitral regurgitation, a large coaptation gap, flattened anterior mitral leaflet (aml), a tethered posterior mitral leaflet (pml), and a history of chronic atrial fibrillation.Due to high-surgical risks, a mitraclip procedure was performed.Both leaflets were grasped with an xtw clip.Grasping was noted to be difficult due to a large coaptation gap which was caused by a flattened aml and hamstringing of a tethered pml.After several attempts with independent grasping, the clip was inverted and pulled back to the left atrium from the left ventricle, the clip delivery system (cds) was posteriorly bent and the clip unintentionally contacted the posterior left atrial wall.Transesophageal echocardiography (tee) revealed a banding structure attached to the left atrium, suggesting iatrogenic la dissection (latd).After the successful clip procedure, toe confirmed no further complications.The patient had an uneventful clinical course under an anticoagulation therapy with warfarin (therapeutic range of prothrombin time- international normalized ratio, 2.0¿2.6).Follow-up toe after 6 months showed spontaneous healing of the iatrogenic latd.The potential risk of device contact with the la wall due to unintentional remaining forces in clip-delivery systems requires more attention to prevent this phenomenon, especially in cases with challenging morphologies for mitraclip therapy.Details are listed in the attached article titled, "spontaneous healing of iatrogenic left atrial dissection: a rare complication of mitraclip therapy.".

Manufacturer Narrative

B5: the malfunction/ product problem reported in the article was captured under a separate medwatch report (report ref #: 2135147-2023-02365-00) in error and is now combined in this report.B3: date of event was estimated.D4: lot numbers were not provided.D6a: date of implant was estimated.The device was not returned for analysis.The lot history record (lhr) review and complaint history review were not performed because this incident was based on an article review and no lot information was provided.Based on available information, the reported difficult or delay positioning (leaflet grasping) was due to challenging anatomy.A cause of the reported unintended movement associated with the posterior bending could not be determined.The reported tissue injury (left atrial dissection) was due to the unintended movement.The reported patient effect of tissue injury, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported medication required was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 health effect - clinical codes 3160 was removed b5: the malfunction/ product problem reported in the article was captured under a separate medwatch report (report ref #: 2135147-2023-02365-00) in error and is now combined in this report.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• 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: 17030180
• MDR Text Key: 316293591
• Report Number: 2135147-2023-02366
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0705-XTW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 07/10/2023
• 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
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male