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

Catalog Number SGC0301

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/29/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is filed under separate medwatch report number.

Event Description

This is filed to report atrial septal damage.It was reported that a mitraclip procedure was performed to treat a degenerative mitral regurgitation with grade of 4+.The patient was presented with left atrial dilatation, prolapsed posterior leaflet, flail posterior leaflet.During the procedure, the physician noted that the ¿+¿and ¿-¿ knob of the steerable guide catheter (sgc) were used.When the ¿+¿and ¿-¿ knobs were used, it was noted that the atrial septal was damaged.An xtr clip was advanced to the left ventricle.It was noted that visualization was challenging due to patient¿s anatomy.During grasping attempts, the clip got caught in chordae.Multiple attempts were performed to free the clip, but the clip was not able to be freed.It was decided to grasp both leaflets and deploy the clip.Although the clip was deployed, the mr grade did not improve.It was thought that the leaflets were not grasped enough, and chordal rupture was observed.It was decided to abort the procedure with one clip implanted and unchanged mr of grade 4+.No additional information was provided.

Event Description

It was reported that a mitraclip procedure was performed to treat a degenerative mitral regurgitation with grade of 4+.The patient was presented with left atrial dilatation, prolapsed posterior leaflet, flail posterior leaflet.During the procedure, the physician noted that the ¿+¿and ¿-¿ knob of the steerable guide catheter (sgc) were used.When the ¿+¿and ¿-¿ knobs were used, it was noted that the atrial septal was damaged.It was thought that the fastener of sgc could not make the sgc stable on the stabilizer.An xtr clip was advanced to the left ventricle.It was noted that visualization was challenging due to patient¿s anatomy.During grasping attempts, the clip got caught in chordae.Multiple attempts were performed to free the clip, but the clip was not able to be freed.It was decided to grasp both leaflets and deploy the clip.Although the clip was deployed, the mr grade did not improve.It was thought that the leaflets were not grasped enough, and chordal rupture was observed.It was decided to abort the procedure with one clip implanted and unchanged mr of grade 4+.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported unstable was not confirmed via returned device analysis.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 was unable to determine a cause for the reported unstable.The reported perforation (damaged atrial septal) appears to be related to procedural condition.Perforation is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no intervention performed to address the perforation there is no indication of a product issue with respect to manufacture, design, or labeling.2993 removed.

• 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: 17596673
• MDR Text Key: 321659991
• Report Number: 2135147-2023-03662
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Catalogue Number: SGC0301
• Device Lot Number: 30328R1009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: Asian