MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP; MITRA VALVE REPAIR

Lot Number 90320U127

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Scar Tissue (2060); Tissue Damage (2104)

Event Date 04/25/2019

Event Type  Injury  

Event Description

The patient was a direct admit for mitral valve clip and tricuspid valve.Mitral valve clip successful.However, while placing the mitra clip in the tricuspid valve during the adjustment of clip, the mitra clip was stuck in the septal commissure and could not be removed easily.After multiple maneuvers, the clip was able to be removed, however it was everted and could not be removed through the guide.Vascular surgery was consulted for removal of foreign body from the right femoral vein.A perclose device was seen partially deployed in the right common femoral vein and the sheath containing the mitral clip was in place.An attempt was made to removed; however, there was profuse bleeding in the right groin.Hence, a transverse cutdown was made in the right groin.Incision was deepened through the subcutaneous tissue and fascia.Due to multiple cardiac catheterization procedures, there was extensive scar tissue.The access site of the right common femoral vein was identified; however, secondary to bleeding, it was difficult to obtain complete exposure of the right common femoral vein proximally and distally.Hence, the mitral clip, which was partially seen out of the femoral vein puncture hole was removed partially and then another part of the mitral clip, which was seen in the medial aspect of the femoral vein was removed under fluoroscopy and while doing the procedure, venotomy of the right common femoral vein was enlarged.At this point there was profuse bleeding from the femoral vein proximally and distally, and also from the profunda femoral vein.Multiple attempts to repair the femoral vein was not possible.Hence, the femoral vein was ligated at the level above the profunda femoral vein.Adequate hemostasis at this point was achieved and this was communicated to the cardiologist.The wound was irrigated well with saline and closed uninterruptedly with a nylon and packed.

Event Description

The patient was a direct admit for mitral valve clip and tricuspid valve.Mitral valve clip successful.However, while placing the mitra clip in the tricuspid valve during the adjustment of clip, the mitra clip was stuck in the septal commissure and could not be removed easily.After multiple maneuvers, the clip was able to be removed, however it was everted and could not be removed through the guide.Vascular surgery was consulted for removal of foreign body from the right femoral vein.A perclose device was seen partially deployed in the right common femoral vein and the sheath containing the mitral clip was in place.An attempt was made to removed; however, there was profuse bleeding in the right groin.Hence, a transverse cutdown was made in the right groin.Incision was deepened through the subcutaneous tissue and fascia.Due to multiple cardiac catheterization procedures, there was extensive scar tissue.The access site of the right common femoral vein was identified; however, secondary to bleeding, it was difficult to obtain complete exposure of the right common femoral vein proximally and distally.Hence, the mitral clip, which was partially seen out of the femoral vein puncture hole was removed partially and then another part of the mitral clip, which was seen in the medial aspect of the femoral vein was removed under fluoroscopy and while doing the procedure, venotomy of the right common femoral vein was enlarged.At this point there was profuse bleeding from the femoral vein proximally and distally, and also from the profunda femoral vein.Multiple attempts to repair the femoral vein was not possible.Hence, the femoral vein was ligated at the level above the profunda femoral vein.Adequate hemostasis at this point was achieved and this was communicated to the cardiologist.The wound was irrigated well with saline and closed uninterruptedly with a nylon and packed.

• Brand Name: MITRACLIP
• Type of Device: MITRA VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 3885 bohannon drive; menlo park CA 94025
• MDR Report Key: 8573027
• MDR Text Key: 143834468
• Report Number: 8573027
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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 Lot Number: 90320U127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29930 DA
• Patient Weight: 72