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

Catalog Number CDS0706-XTW

Device Problem Entrapment of Device (1212)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Respiratory Failure (2484); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 10/31/2023

Event Type  Injury  

Event Description

This report is being conservatively filed as a serious injury against the last implanted xtw mitraclip.This mitraclip was possibly deployed with chordae and the post-mitral valve replacement events were deemed possibly related to the mitraclip device.Crd_947 - repair mr ide study.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 and 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) re-crossed the septum at a lower position.Following, two xtw mitraclips were successfully delivered and deployed without issues.There was some difficulty with visualization following due to the previously implanted clips.An xt mitraclip was selected for treatment.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 (cds0706-xtw, 30711r2026) 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 (b)(6) 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.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.

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 and d10 is being filed under a separate medwatch report number.

Event Description

(b)(6) - repair mr ide study.Patient id: (b)(6).It was reported that on 10/31/2023, 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 (cds0706-xtw, 30726r1115) 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) sgc0701, 30817r1075)) re-crossed the septum at a lower position.Following, two xtw mitraclips (cds0706-xtw, 30601r1084 and 30711r2025) were successfully delivered and deployed without issues.An xt mitraclip (cds0706-xt, 30306r1120) 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 (cds0706-xtw, 30711r2026) 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 (b)(6) 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.

Manufacturer Narrative

All available information was investigated and the reported entrapment of device and poor image resolution during procedure 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 reported from this lot.The investigation determined the reported poor image resolution was due to presence of other clips.However, a cause for the reported entrapment of device cannot be determined.In additions, cause for the reported recurrent mr and lactic acidosis resulting in renal failure was also undetermined cannot be determined.The hypotension, arrhythmia, pericardial effusion, cardiac tamponade, respiratory failure, and shock appear to be cascading effects.Mr, heart failure, hypotension, renal failure, test rest (lactic acidosis), arrhythmia, pericardial effusion, cardiac tamponade, respiratory failure, and shock are listed in the instructions for use as known possible complications associated with mitraclip.The reported hospitalization, unexpected medical intervention, and surgical intervention were results 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 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: 18181494
• MDR Text Key: 328631768
• Report Number: 2135147-2023-05111
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: 30711R2026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• 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: 2 IMPLANTED MITRACLIPS.; STEERABLE GUIDE CATHETER.
• Patient Outcome(s): Hospitalization; Disability; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White