MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problems Incomplete Coaptation (2507); Expulsion (2933); Physical Resistance/Sticking (4012)

Patient Problems Syncope/Fainting (4411); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  Injury  

Event Description

This is filed to report single leaflet device attachment/slda.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation with a grade of 4.It was noted posterior prolapse and flail.The clip delivery system (cds) was advanced to the mitral valve; however when trying to grasp the posterior flail, the clip briefly interacted with chordae.The clip was ultimately able to grasp the flail and deploy the clip on both leaflets without issue.However, the brief interaction between the clip and the chordae caused some shadowing on the imaging and the anterior leaflet was difficult to see.One clip was implanted, reducing mr to 1.Then hours later, imaging showed the clip became detached from the anterior leaflet, but remained attached to the posterior leaflet (single leaflet device attachment/slda).The physician stated that the cause of the slda is unknown.Since the clip appeared stable and mr was still 1, additional treatment was not needed.The patient is stable and discharged as planned.No other information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the available information, a cause for the single leaflet device attachment/slda) could not be determined.The reported interaction between the device and anatomy appears to be a result of procedural conditions/user technique (grasping below valve).The reported poor imaging appears to be a cascading event of the interaction between the device and anatomy.There is no indication of a product issue with respect to manufacture, design, or labeling.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on the available information, the single leaflet device attachment (slda) appears to be due to procedural conditions.The reported interaction between the device and anatomy appears to be a result of procedural conditions/user technique (grasping below valve).A cause for the reported expulsion could not be determined.The reported poor imaging appears to be due to procedural conditions.A cause for the reported fainting could not be determined.The reported patient effects of embolism and mitral regurgitation (mr) are cascading events of the expulsion.Additionally, embolism and mr are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization, unexpected medical interventions, and removal of foreign body were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

Subsequent to the follow up report filed, the following additional information was received: on 5/26/2022, the patient was re-admitted and underwent a second mitraclip procedure.Two additional clips were implanted, reducing mr from 4+ to 1-2+.No other information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.A cause for the reported fainting could not be determined.It is possible that worsening patient condition contributed to this event.However, this cannot be confirmed.The reported embolism and mitral regurgitation (mr) are cascading events of the expulsion.Additionally, embolism and mr are listed in the mitraclip g4 system instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported interaction between the device and anatomy appears to be a result of procedural conditions/user technique (grasping below valve).The reported hospitalization, unexpected medical intervention, and removal of foreign body were the results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.H1 - type of reportable event: updated from 'malfunction' to 'serious injury' h6 - patient codes 2199 and 4582 were removed.H10 - addtl mfg narrative: revised.

Event Description

This is filed to report embolized clip, prolonged hospitalization, and medical intervention.Subsequent to the final report filed, the following additional information was received: then on 3/20/2022, the patient passed out and collapsed.The patient was re-hospitalized and then it was discovered that clip came off both leaflets, embolizing to the subclavian artery and increasing mr to 4.The embolized clip was retrieved with a snare.The patient is stable and was discharged on 3/24/2022.No other information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14074562
• MDR Text Key: 289019924
• Report Number: 2024168-2022-03853
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• 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,Followup
• Report Date: 06/17/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 11026R166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 05/27/2022
• Supplement Dates FDA Received: 05/20/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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; Hospitalization