MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-NTW

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Reportedly, the device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced is filed under separate medwatch report number.

Event Description

This report is being filed as the implanted clip was dislodged by another device and removed via surgery.It was reported that on (b)(6) 2021, the patient presented with severe degenerative mitral regurgitation (mr).During transseptal access and before any mitraclip device was used, a blood clot was observed on the ts wire.The sheath was flushed, removing the clot.No further clot was observed by echo.The mitraclip procedure continued and steerable guide catheter (b)(4) was placed.The first mitraclip (b)(4) was successfully implanted on the lateral a2p2 with a good grasp and good mr reduction.The mr was reduced to grade 2 and mean mitral valve gradient was 1mmhg.After deployment, additional mr jets were on noted on both sides.Reportedly, the ntw mitraclip remained stable and well seated without any tissue injury, no device issue, and the mr remained grade 2.A second clip delivery system (cds0701-nt 00416u130) advanced.The initial grasp was not satisfactory as it was performed with difficult visualization.There was no device issue with the difficulty grasping, and the difficulty with visualization was only with this second mitraclip due to the available imaging.The nt mitraclip was attempted to be inverted for re-positioning.At this time, the nt mitraclip had interacted with chordae and was difficult to remove from the chordae.Standard troubleshooting was performed, and the clip was successfully removed from the chordae.The nt mitraclip was retracted back into the left atrium and a new flail was observed.At this time, the mitraclip team discussed removing the second clip delivery system (cds) and not deploying this nt mitraclip.The nt mitraclip was advanced and again interacted with the chordae.Standard troubleshooting was performed, and the nt mitraclip was retracted back into the left atrium.At this time, a larger flail was observed.The implanter began to attempt to grasp the new flail created with the nt mitraclip.They were unable to grasp the flail and during this attempt, the nt mitraclip, interacted with the previously implanted ntw mitraclip, causing the previously implanted ntw mitraclip to detach from the posterior leaflet, while remaining attached to the anterior leaflet, a single leaflet device attachment (slda).The patient started becoming hypotensive and the procedure was paused for an intra-aortic balloon pump (iabp) placement.At this time, the av representative discussed the need for surgery and reached out to this accounts av manager, (b)(6), who also recommended surgery.At this time, the physician attempted to close the nt mitraclip and remove into the sgc.The av representative had then observed the nt mitraclip as detached from the delivery system mandrel, while held by the lines.Per physician, the clip was unable to fully close for retraction into the sgc.The clip detachment is thought to have occurred during nt mitraclip removal attempt into the sgc (although unsuccessful as the clip did not enter the sgc tip).The implanter reports that he then inverted the clip and retracted all, sgc along with the nt mitraclip cds to the groin.The clip was not stuck on the sgc tip but was rather resting just off the sgc tip, not fully closed.The av rep and physician discussed multiple ways to proceed.All was retracted to the groin and the lines were cut, leaving the clip within the groin area per fluoroscopy.The groin was stitched, and the left for a mitral valve replacement and removal of the detached clip, located in the groin site that same day.The mr remained severe, however looked worse than pre-procedure.Reportedly, the mitral valve replacement was performed due to the slda ntw mitraclip and due to the worsening mr and flail, created during nt mitraclip use.The ntw mitraclip had been explanted during the mitral valve replacement that same day, (b)(6) 2021.Reportedly, the patient had been improving, however, the family decided to withdrawal care, take the patient off the ventilator, and the patient expired on (b)(6) 2021.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no other similar complaints reported from this lot.All available information was investigated, and the reported device damaged by another device appears to be due to procedural circumstances/operational context.However, the reported single leaflet device attachment (sdla) appears to be due to the reported device damaged by another device.The reported surgical intervention appears to be due to case specific circumstances as the patient underwent mitral valve replacement due to slda caused during the procedure.Based on the information reviewed, there is no indication of product issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Nab5.

Event Description

Subsequent to the previous medwatch report, corrected information was received: after intra-aorta balloon pump (iabp) placement, the abbott vascular (av) representative discussed further actions with the physician and av manager.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11340501
• MDR Text Key: 232337291
• Report Number: 2024168-2021-01276
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2021

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: 05/05/2021
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 00506U169
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 02/26/2021; 03/29/2021
• Supplement Dates FDA Received: 03/07/2021; 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 79 YR
• Patient Weight: 56