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

Catalog Number CDS0601-XTR

Device Problems Positioning Failure (1158); Off-Label Use (1494); Difficult to Remove (1528)

Patient Problems Air Embolism (1697); Fistula (1862); Tissue Damage (2104); Tricuspid Regurgitation (2112)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device 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 the difficult removal, tissue damage, fistula and air embolism.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with a tr grade of 4.Two clips were implanted, to further reduce tr, a third clip was advanced, however due to difficult imaging the clip got stuck on the chordae.The clip was freed, and a small chordae rupture occurred.Air bubbles were observed in the right side of the heart, near the superior vena cava.It is the physician¿s opinion the patient had subcutaneous emphysema and that during grasping; when the patient¿s chest was pressed, to help facilitate the grasp, a fistula may have occurred.Air was not observed in the cds or sgc.Air resolved on its own, grasping attempts were continued but due to imaging and anatomy, the leaflets could not be grasped.The clip was not implanted.A total of two clips were implanted.Tr remains at 4.The patient remained stable.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 contributed to this event.Additionally, a review of the complaint history did not identify any similar incidents from the reported lot.Based on the information reviewed, the reported difficult to remove from anatomy (chordal entanglement) was due to difficult imaging, therefore due to procedural circumstances.The reported positioning grasping failure was due to a combination of patient anatomy (tricuspid leaflets were too far apart) and difficult imaging, therefore due to procedural circumstances.The reported air embolism was due to procedural circumstances as air bubbles were observed in the right side of the heart, near the superior vena cava during the procedure.The reported fistula was also due to procedural circumstances.The reported unchanged tricuspid regurgitation (tr) was because of the attempt to implant the clip on the tricuspid valve, however, the clip was not implanted, therefore it was due to procedural conditions.It should be noted that the reported patient effects of mitral valve tissue damage, arterio-venous fistula, air embolism as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.In this incident the account indicated that this mitraclip procedure included treating tricuspid regurgitation (tr).It should be noted that, per the intended use section of the mitraclip system ifu, "the mitraclip® system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation.The off-label use appears to have contributed to the reported issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9173364
• MDR Text Key: 161812555
• Report Number: 2024168-2019-12475
• 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: 11/19/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90607U136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED CLIPS X2; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other