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

Catalog Number CDS0601-XTR

Device Problems Off-Label Use (1494); Failure to Advance (2524)

Patient Problems Tissue Damage (2104); Tricuspid Regurgitation (2112)

Event Date 08/28/2019

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 being filed to report during the procedure tissue damage occurred.It was reported that this was a mitraclip procedure to treat tricuspid regurgitation (tr) with grade of 3+.The clip delivery system (cds) was advanced without issue; however, there was not enough height as the physician was unable to get a perpendicular trajectory through the valve because the distance was too short.It was difficult to position the clip, so the clip could not be implanted.The cds and clip were removed.A small chordae tear was noted during the procedure.Although, there was no clip entanglement, the chordae tear was likely from the device/procedure as it was not present pre-procedure.The procedure was aborted, tr remained at 3+.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 identified no similar incidents reported from this lot.It should be noted as per the mitraclip ntr/xtr instructions for use (ifu): the mitraclip system is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation.All available information was investigated and the reported off-label use in the tricuspid valve likely resulted in failure to advance and tissue damage, and appears to be related to user error.Unchanged tricuspid regurgitation (tr) was a result of procedural conditions.The reported patient effect of tissue damage as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.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: 9082800
• MDR Text Key: 159010538
• Report Number: 2024168-2019-11874
• 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: 10/25/2019

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: 03/31/2020
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 90329U110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 53