MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0701

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

Patient Problem Perforation (2001)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

The xtw mitraclip deployed with possible chorea referenced in b5 and d10 is filed under a separate medwatch report number.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The investigation was unable to determine a cause for the reported perforation.Perforation is listed in the instructions for use as a known possible complication associated with the mitraclip procedures.The reported surgical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This report is being filed against the steerable guide catheter with a clinically significant atrial septal defect following use.(b)(6).Patient id: (b)(6).It was reported that on (b)(6) 2023, the patient presented with degenerative mitral regurgitation (mr) grade 4, with posterior leaflet flail and large atrium.A high transeptal was performed.The first xtw mitraclip advanced to the mitral valve.Grasping was difficult and the anterior leaflet became stuck on the gripper.Standard troubleshooting was performed, removing the clip.The device was removed.There was no tissue injury associated with this clip.It was decided to re-cross the septum to improve transeptal height.The same steerable guide catheter ((sgc) (b)(6) re-crossed the septum at a lower position.Following, two xtw mitraclips were successfully delivered and deployed without issues.An xt mitraclip was then selected for treatment.There was some difficulty with visualization following due to the previously implanted clips.The xt mitraclip was positioned between the previous two xtw clips without any device issue, however, the mr was not reduced as expected.The xt was not implanted and removed from the patient.Reportedly, this was a sizing issue.There was no device malfunction or injury associated with this clip.A mitraclip xtw was then selected for treatment and advanced to the mitral valve.During use this clip became stuck on the previously implanted second clip.There was no damage to the second deployed clip.The clip was deployed on both leaflets, possibly with some chordae, stable and without any injury observed.The procedure had been completed with three clips implanted.The mr was reduced to grade 3-4.There was no clinically significant delay in the procedure and no adverse patient effects.Starting on 11/01/2023, the patient had become hypotensive with worsening lactic acidosis, stress hyperglycemia, worsening renal function with acute kidney injury were noted.The patient was going into cardiogenic shock with lactic acidosis.The patient returned to hospital in an unstable condition, hypotensive, decompensating, with recurrent mr grade 4.On (b)(6) 2023, an elective mitral valve replacement was performed.During the replacement, a large amount of blood was evacuated from the right chest with a moderate pericardial effusion.Hemostasis was achieved, the area was packed, and blood/blood product transfusions were provided.A left atrial appendage (pre-existing condition) was treated along with an atrial septal defect (asd) closure with surgical repair.Per physician, the asd was related to the sgc.There was no device malfunction regarding the sgc reported.Post-procedure, the patient went into acute respiratory failure.Cardiac arrhythmias were also observed.A pericardial effusion with pericardial tamponade were noted.The patient returned to the operating room for treatment (a wash out).Per physician, the events following the mitral valve replacement were possibly related to the mitraclip device.The events resolved.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• 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: 18301823
• MDR Text Key: 330230918
• Report Number: 2135147-2023-05424
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 30817R1075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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: FIVE CLIP DELIVERY SYSTEMS.
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White