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

Catalog Number CDS0706-XTW

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Ischemia (1942); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/12/2023

Event Type  Injury  

Event Description

This is filed to report a device caught in the chordae, difficulty removing the cds from the sgc, left ventricular outflow obstruction, and intervention.It was reported that a patient presented with grade 4+ degenerative mitral regurgitation (mr) and a lateral leaflet flail for a mitraclip procedure.Upon positioning the clip delivery system (cds), the clip became caught in the posterior chordae.Troubleshooting, such as torqueing the guide anteriorly to attempt to free the clip was unsuccessful, and possibly contributed to further entanglement.It was noted that during anterior torque maneuvers, the anterior leaflet was pinned, resulting in an temporary increase in mr and possible left ventricular outflow tract obstruction (lvoto).Intervention from anesthesia had to support the patient when this occurred.The clip was torqued back posteriorly.The clip had to be deployed and was grasped on the lateral aspect of the valve.Adequate leaflet insertion on both anterior and posterior leaflets was confirmed, and the clip was deployed without incident.It was noted that once the leaflet was grasped, the mr reduced and the patient stabilized.The final mr reduction was grade 2+.The cds was unable to be completely removed from the steerable guide catheter (sgc).Resistance was noted during an attempt to retract the cds.The mitraclip system was removed as one unit after special wire access through the steerable guide catheter (sgc) wall was manually achieved closer to the groin.The patient was stable.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The steerable guide catheter (sgc) referenced in b5 is filed under a separate medwatch report.

Manufacturer Narrative

In this case, the reported difficult to remove ¿ cds/sgc (clip delivery system/steerable guide catheter) was confirmed as the cds was returned inserted in the sgc hemostasis valve and the cds was difficult to remove from the sgc as returned.The reported entrapment of device component-clip caught on chordae could not be replicated in a testing environment.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints from the lot.Based on the information provided and the analysis of the returned device, the difficult to remove the cds from the sgc appears to be related a potential product issue with the sgc and is not related to the cds.A cause for the reported entrapment of device associated with the clip becoming caught on chordae, however, cannot be determined.Ischemia and heart failure appears to be related to procedural conditions and user technique associated with the clip becoming entangled with the anatomy and the attempts to free it.The reported patient effects of ischemia and heart failure are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Medication required and unexpected medical intervention were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL NORTHPOINT REG 3020950818; 1820 bastian court; westfield IN 46074
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17889659
• MDR Text Key: 325227109
• Report Number: 2135147-2023-04376
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037381
• UDI-Public: 05415067037381
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: CDS0706-XTW
• Device Lot Number: 30621A1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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: 86 YR
• Patient Sex: Female