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

Model Number CDS0601-NTR

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) 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.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The steerable guide catheter referenced is filed under a separate medwatch report number.

Event Description

This is filed to report difficult removal of the mitraclip delivery system (cds).It was reported this was a mitraclip procedure performed to treat grade 4 tricuspid regurgitation (tr).During the procedure, after turning the +/- knob 2/3 of a turn, the steerable guiding catheter (sgc), no longer curved or straightened, but use of the device continued.The mitraclip delivery system (cds) was advanced and the clip was implanted without issue, reducing tr to grade 1.During removal of the cds, it could not be completely retracted through the sgc, so the devices were removed together as single unit.The radiopaque alignment markers on the sleeve shaft were observed to be too separated when the system was fully retracted.There was no reported adverse patient effect or a clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported issues of difficulty to remove and misassembled (radiopaque alignment markers too separate) could not be confirmed as no issues were noted during returned device analysis.A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents reported from this lot.The device was used in the tricuspid valve (off-label use was due to user error).It should be noted the instructions for use states, the mitraclip system is intended for reconstruction of the insufficient mitral valve through tissue approximation.There is no indication that the off-label use of the mitraclip device influenced the reported events.All available information was investigated and a cause for the reported difficult to remove and misassembled cannot be determined.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: 8994996
• MDR Text Key: 157869125
• Report Number: 2024168-2019-11705
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648226342
• UDI-Public: 08717648226342
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90429U170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Age: 62 YR
• Patient Weight: 65