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

Catalog Number SGC0302

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional device referenced is being filed under a separate medwatch report.

Event Description

This is filed to report a broken hemostasis valve.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Prior to the procedure, it was noted that the patient had very friable leaflets.The clip delivery system (cds) (91205u230) was inserted into the steerable guide catheter (sgc) (00213u344), but it was noticed that the sgc was facing in a posterior direction, but the clip was positioned in the anterior direction.This caused the sgc to be move in an abnormal direction.Therefore, the cds was attempted to be removed, but during removal the clip became stuck on the hemostasis valve of the sgc.It was then noticed that the hemostasis valve was broken; therefore, the sgc was removed from the stabilizer and placed below the heart to prevent the insertion of air.The physician was then able to remove both the cds and sgc without further issues.It was noted that the difficulty removing the clip was caused by the cds.A new sgc was inserted and one clip was successfully implanted on the lateral side of a2p2.To further reduce mr, an additional clip (91105u165) was implanted medially of the first clip.A remaining jet was noticed; therefore, a third clip was inserted and implanted at a3p3.However, after the third clip was implanted, it was noticed that the second clip caused a tear on the posterior leaflet.No additional clips were implanted mr reduced to a grade of 2-3.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported irregular appearance (incorrect angle) of the distal shaft of the steerable guide catheter and break on the hemostasis valve could not be 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 determined the reported issue appears to be related to the user perception of the device as no issue was observed with the device.A cause for the reported break cannot be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10385901
• MDR Text Key: 202795461
• Report Number: 2024168-2020-06647
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00213U344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 86 YR
• Patient Weight: 50