MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; VALVE REPAIR

Catalog Number CDS0502

Device Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354); Deformation Due to Compressive Stress (2889)

Patient Problems Air Embolism (1697); Cardiac Enzyme Elevation (1838)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip and steerable guide catheter devices referenced are being filed under separate medwatch report numbers.

Event Description

This is filed to report the air entering the patient (00403u115).It was reported this was a mitraclip procedure performed to treat grade 3-4 degenerative mitral regurgitation (mr).The steerable guide catheter (00308u206) and mitraclip delivery system (cds) (00402u208) were advanced.The saline bag was inspected, there was no saline dripping from the side port of the three-way stopcock, so it was decided to retract the cds from the sgc for inspection.When removing the cds, the clip introducer could not be removed from the sgc, it was observed that the clip was slightly open.The cds was removed.The clip was noted to be damaged and the clip cover tore/unraveled during removal.The same sgc was continued to be used.A new cds (00403u115) was prepped and this time the saline solution successfully dripped from the bag.However, when advancing the cds to the left atrium the water level in the cds handle dropped, air entered the cds handle.Therefore, the cds red cap was opened and the water level in the cds was filled for flushing letting the air escape.At this time, air entered the left ventricle and the ascending aorta and st increased.The patient's head was lowered, and air was removed from the left ventricle and ascending aorta with a catheter.Echocardiogram confirmed no more air in the patient and st also recovered normally.The procedure was continued with the same cds.Grasping was difficult due to the short posterior leaflet.During grasping attempts, the water level in the handle of the cds dropped twice, air entered the cds handle.The cds was flushed and air was removed from the device, no more air entered the patient.When retracting the cds from the left ventricle, it is suspected the clip got caught on tissue or chordae and the cds shaft bent.The clip was freed from tissue under the valve or chordal without causing injury.The clip was implanted, and mr was reduced to 1-2.No post-operative follow-up observations have reported any health problems.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the clip cover was not damaged during removal; however, the clip introducer was torn during retraction of the open clip.The side of the clip cover was observed unraveling slightly.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported leak (air entered handle) and bent shaft was not confirmed via returned device analysis.The reported difficulty leaflet grasping, and difficult or delay positioning (clip caught on anatomy), during use could not be replicated in a testing environment.The discrepancy between what was reported (air entered handle and bent shaft), and what was observed (no air entering handle and no bent shaft) may have been due to user technique of de-airing or advancing the device and clip caught on anatomy, respectively.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 did not indicate a lot-specific quality issue.Air embolism and cardiac enzyme elevation are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the reported leaks and clip caught on anatomy.The reported difficulty grasping was due to the patient anatomy (short posterior leaflet) and the reported bent shaft appears to be related to the clip caught on anatomy.The patient effect of cardiac enzyme elevation appears to be related to the air embolism and the embolism was due to the procedural condition of the leaks.There is no indication of a product issue with respect to manufacture, design, or labeling.H10: there were no issues with the steerable guide catheter; therefore, it was not reported.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10445790
• MDR Text Key: 204240058
• Report Number: 2024168-2020-07048
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• 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: 09/21/2020

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 Expiration Date: 04/06/2021
• Device Catalogue Number: CDS0502
• Device Lot Number: 00403U115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 53