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

Model Number N/A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022 a mitraclip procedure was performed to treat grade 4+ functional mitral regurgitation (mr) with a rotated heart, large left atrium, restricted p2 scallop, difficult t.S.Resulting in aorta hugger.An xtw clip was being used when the anterior gripper line detached from the clip prior to deployment.Physicians had been unable to reposition clip, however, it was deployed successfully with adequate leaflet insertion.A second clip was implanted without issue reducing mr to 2+.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported break for the controlled gripper actuation (cga) gripper line was unable to confirm via returned device analysis.The reported entrapment of device as clip caught on the chordae could not be replicated in a testing environment as it was related to patient/procedural (operational) circumstances.A review of the lot history identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information reviewed, a cause for the reported break on gripper line cannot be determined.The reported entrapment of device as clip caught on the chordae appears to be related to challenging patient anatomy (rotated heart, large left atrium, restricted p2 scallop, difficult t.S.Resulting in aorta hugger).Additionally, the reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H1: report type updated to serious injury.H6: impact code 2199 was removed.

Event Description

This is filed to report the clip becoming entrapped requiring intervention and a broken gripper line.Subsequent to the previously filed report, additional information was received: it was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.An xtw clip was advanced in the patient and during positioning it was noted on echo and fluoro that the anterior gripper line detached from the clip.The physician was having difficulty positioning the clip and suspected that a chord was entangled on the clip arm.The clip was unable to be removed or repositioned due to the entanglement.In order to avoid injury the physician decided to the deploy the clip.The clip had adequate leaflet insertion and was deployed on both leaflets with chordae.The clip was observed to be stable and an additional clip was implanted to further reduce the mr.The procedure was complete with a final mr grade of 2+.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 15577285
• MDR Text Key: 306432890
• Report Number: 2135147-2022-01570
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: N/A
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 20510R267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 132 KG