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

Model Number CDS0601-XTR

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915); Expulsion (2933)

Patient Problems Death (1802); Embolism (1829); Tissue Damage (2104)

Event Date 12/02/2020

Event Type  Death  

Manufacturer Narrative

The clip was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report death, tissue damage, single leaflet device attachment (slda), device dislodged and compete clip detachment.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Prior to inserting the devices, it was noted that the patient was in very poor health, had thin leaflets and substantial sub valvular calcification.An xtr clip (00623u167) was inserted and successfully deployed.To further reduce mr, an ntr clip (00630u125) was inserted and attempted to be implanted laterally of the xtr clip.However, while positioning the ntr clip, it came in contact with the implanted clip, causing it to detach from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda).It was noted that the slda caused damage to the anterior leaflet and the chordae.To stabilize the slda, the ntr clip was successfully deployed.To further stabilize the slda and to treat a large jet medially of the slda, an additional xtr clip (00718u126) was inserted.The clip was advanced under the valve, but while under the valve, the clip unintendedly jumped in a lateral direction and became caught on the clip arm of the implanted xtr clip.The two clips were able to be removed from each other and the third clip attempted to grasp the leaflets, but due to the tissue damage that had already occurred, the leaflets were unable to be grasped; therefore, the clip was removed.After removing the third clip, it was noticed that the first xtr clip had detached from the posterior leaflet and become embolized under the valve.To retrieve the clip, the physician inserted a snare.The clip was successfully snared, but while removing the clip, it became stuck in the femoral vein, causing a clinically significant delay in the procedure.The clip had to be surgically removed.The procedure was discontinued after retrieving the clip from the femoral vein.Mr remained at a grade of 4.It was noted that the patient is in a stable condition.Three days later, the patient passed away.The physician stated that the inability to implant the clip contributed to the patient death.No additional information was provided.

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 complaint.Additionally, a review of the complaint history identified no lot specific product issue.All available information was investigated, and the reported device damaged by another device and complete clip detachment were a result of procedural circumstances/user technique.The reported single leaflet device attachment (slda) was due to the reported device damaged by another device.The reported patient effects of tissue damage (mitral valve injury) and embolism were due to slda.The reported death was an outcome of procedural circumstances/operational context.The reported patient effect of tissue damage, death and embolization, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11065264
• MDR Text Key: 223400152
• Report Number: 2024168-2020-10887
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226366
• UDI-Public: 08717648226366
• 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
• Report Date: 02/23/2021

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: 06/24/2021
• Device Model Number: CDS0601-XTR
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 00623U167
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER; CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Weight: 88