MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 12/20/2023

Event Type  Death  

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 a patient presented with grade 4 degenerative mitral regurgitation (mr) and posterior leaflet flail for a mitraclip procedure.The transseptal puncture, guide insertion, and steering down to the valve were all done without any issues.Upon closing cds0706-xtw (30922r1093) a minor reduction was seen, but the posterior flail segment and majority of the mr still remained.The grippers were raised, but the anterior leaflet still appeared to be attached.Greater than 10 attempts were made free the gripper, such as; cycling the grippers and manipulating / maneuvering the clip were unsuccessful.Finally, with heavy guide manipulation, the clip was freed.At this point, the mr worsened (severe), and a new anterior flail was noted.The xtw clip was fully retracted and removed.Tissue was observed in the gripper.At this time, it was noted that the location of the septal crossing had changed.The septum had torn from the original mid-posterior position all the way to a mid-anterior position by the steerable guide catheter (sgc-30830r1068).The procedure was continued to stabilize the mr and the two flails on the valve.The next clip, cds0706-xtw (30928r1099) was placed on the medial side of the valve.Although, the lack of height presented a challenging, off axis grasp, successful leaflet insertion was achieved and a small reduction of mr was noted.Next, cds0706-xt (21222r1043) was inserted and used to target the new flail.Grasping was challenging due to lack of height from the torn septum.After many attempts, leaflet insertion was confirmed.The physician had difficulty releasing the clip, as the dc handle was fully retracted and could not be pulled back any further to confirm a 1cm separation from the clip.The physician attempted to "swivel" the dc handle.He also tried to pull the sgc back in a coaxial manner, but it did not appear to be pulled back coaxial.The sgc was then pulled back with considerable force.A jump with sgc occurred and the clip was pulled off the posterior leaflet with no damage noted.Within about 10 seconds, the clip completely embolized and made its way to the ostium of the right upper pulmonary vein.The sgc was exchanged for a 22 french non-abbott snare catheter to remove the clip.The clip came loose from the snare at the tip of the catheter, but was about to be captured with biopsy forceps and removed from the patient.The patient had severe mr and a large atrial septal defect (asd).The asd was closed with an amplatzer asd occluder.The patient became hemodynamically unstable during the end of the mitraclip and again during the asd procedure.The patient was brought to surgery later in the day, and it is unknown if it is due to the asd or mitraclip procedure.The patient did not make it through recovery overnight.

Event Description

Full procedure description for medical review: it was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr), friable leaflets, and posterior leaflet flail for a mitraclip procedure.The transseptal puncture, guide insertion, and steering down to the valve were all done without any issues.Upon closing cds0706-xtw (30922r1093) a minor reduction was seen, but the posterior flail segment and majority of the mr remained.The grippers were raised, but the anterior leaflet still appeared to be attached.Greater than 10 attempts were made free the gripper, such as cycling the grippers and manipulating / maneuvering the clip were unsuccessful.Finally, with heavy guide manipulation, the clip was freed.At this point, the mr worsened (severe), and a new anterior flail was noted.The xtw clip was fully retracted and removed.Tissue was observed in the gripper.At this time, it was noted that the location of the septal crossing had changed.The septum had torn from the original mid-posterior position all the way to a mid-anterior position by the steerable guide catheter (sgc-30830r1068).The procedure was continued to stabilize the mr and the two flails on the valve.The next clip, cds0706-xtw (30928r1099) was placed on the medial side of the valve.Although, the lack of height presented a challenging and off axis grasp, successful leaflet insertion was achieved, and a small reduction of mr was noted.Next, cds0706-xt (21222r1043) was inserted and used to target the new flail.Grasping on medial posterior leaflet segment 2 (p2) was challenging due to lack of height from the torn septum.After many attempts, leaflet insertion was confirmed.The physician had difficulty releasing the clip.The delivery catheter (dc) handle was fully retracted and could not be pulled back any further to confirm a 1cm separation from the clip.The physician attempted to "swivel" the dc handle.He also tried to pull the sgc back in a coaxial manner, but it did not appear to be pulled back coaxial.The sgc was then pulled back with considerable force.The sgc jumped back and the clip was pulled off the posterior leaflet with no damage noted.Within about 10 seconds, the clip completely embolized and traveled to the ostium of the right upper pulmonary vein.The sgc was exchanged for a 22 french non-abbott snare catheter to remove the clip.The clip came loose from the snare at the tip of the catheter but was able to be captured with biopsy forceps and removed from the patient.During use of the sgc and xt, the patient became hemodynamically unstable (blood pressure dropped to 60s systolic and heart rate was in the low 40s bpm) and required treatment (epinephrine).The patient had severe mr and a large atrial septal defect (asd).The asd was closed with an amplatzer asd occluder, directly after removing the xt with the snare.The patient became hemodynamically unstable during the asd procedure.Per the physician, this was a continued effect from the mitraclip procedure.Due to the outcome of the mitraclip procedure, the patient was emergently placed on cardiopulmonary bypass (cpb) and brought to surgery later in the day.Gross inspection by the surgeon revealed unsalvageable cardiac tissue.Upon opening the chest, blood was observed in the epicardial tissue and pericardium.As the pericardium was opened, the tissues were terribly friable and began to fall apart.The anterior surface of the ventricle was also bleeding, as well as some bleeding back behind the aorta and in the dome of the atrium.This was unable to be controlled, and the patient continued to exsanguinate.The surgery was discontinued, and the patient was removed from cpb.The patient expired on (b)(6) 2023.Initial report procedure description below: it was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and posterior leaflet flail for a mitraclip procedure.The transseptal puncture, guide insertion, and steering down to the valve were all done without any issues.Upon closing cds0706-xtw (30922r1093) a minor reduction was seen, but the posterior flail segment and majority of the mr still remained.The grippers were raised, but the anterior leaflet still appeared to be attached.Greater than 10 attempts were made free the gripper, such as; cycling the grippers and manipulating / maneuvering the clip were unsuccessful.Finally, with heavy guide manipulation, the clip was freed.At this point, the mr worsened (severe), and a new anterior flail was noted.The xtw clip was fully retracted and removed.Tissue was observed in the gripper.At this time, it was noted that the location of the septal crossing had changed.The septum had torn from the original mid-posterior position all the way to a mid-anterior position by the steerable guide catheter (sgc-30830r1068).The procedure was continued to stabilize the mr and the two flails on the valve.The next clip, cds0706-xtw (30928r1099) was placed on the medial side of the valve.Although, the lack of height presented a challenging, off axis grasp, successful leaflet insertion was achieved and a small reduction of mr was noted.Next, cds0706-xt (21222r1043) was inserted and used to target the new flail.Grasping was challenging due to lack of height from the torn septum.After many attempts, leaflet insertion was confirmed.The physician had difficulty releasing the clip, as the dc handle was fully retracted and could not be pulled back any further to confirm a 1cm separation from the clip.The physician attempted to "swivel" the dc handle.He also tried to pull the sgc back in a coaxial manner, but it did not appear to be pulled back coaxial.The sgc was then pulled back with considerable force.A jump with sgc occurred and the clip was pulled off the posterior leaflet with no damage noted.Within about 10 seconds, the clip completely embolized and made its way to the ostium of the right upper pulmonary vein.The sgc was exchanged for a 22 french non-abbott snare catheter to remove the clip.The clip came loose from the snare at the tip of the catheter, but was able to be captured with biopsy forceps and removed from the patient.The patient had severe mr and a large atrial septal defect (asd).The asd was closed with an amplatzer asd occluder.The patient became hemodynamically unstable during the end of the mitraclip and again during the asd procedure.The patient was brought to surgery later in the day, and it is unknown if it is due to the asd or mitraclip procedure.The patient did not make it through recovery overnight.No additional information was provided.Subsequent to the initial report: during use of the sgc and xt, the patient became hemodynamically unstable (blood pressure dropped to 60s systolic and heart rate was in the low 40s bpm) and required treatment (epinephrine).The patient had severe mr and a large atrial septal defect (asd).The asd was closed with an amplatzer asd occluder.The patient became hemodynamically unstable during the asd procedure.Per the physician, this was a continued effect from the mitraclip procedure.Due to the outcome of the mitraclip procedure, the patient was emergently placed on cardiopulmonary bypass (cpb) and brought to surgery later in the day.Gross inspection by the surgeon revealed unsalvageable cardiac tissue.Upon opening the chest, blood was observed in the epicardial tissue and pericardium.As the pericardium was opened, the tissues were terribly friable and began to fall apart.The anterior surface of the ventricle was also bleeding, as well as some bleeding back behind the aorta and in the dome of the atrium.This was unable to be controlled, and the patient continued to exsanguinate.The surgery was discontinued, and the patient was removed from cpb.The patient expired on (b)(6) 2023.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.The investigation determined the reported perforation and death appear to be related to procedural conditions.The reported bradycardia and hypotension appear to be cascading effects.Death, perforation, bradycardia, and hypotension angina are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical interventions, medication required, 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 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• 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: 18488820
• MDR Text Key: 332601157
• Report Number: 2135147-2024-00183
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• 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: 30830R1068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2023
• 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: MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 73 KG