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

Model Number CDS0601-NTR

Device Problems Product Quality Problem (1506); Retraction Problem (1536); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The steerable guide catheter referenced will be filed under another mfr number.

Event Description

This is filed for foreign material noted on the device.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.One clip was implanted without issue.The second clip delivery system (cds) was advanced into the steerable guide catheter (sgc) with some resistance at the sgc hemostasis valve; however, the device was then able to advance.When steering down to the valve, there was some resistance noted when retracting the delivery catheter (dc) handle.On fluoroscopy, an unknown metal object was seen on the cds shaft when testing the clip lock; however, the procedure continued and the clip was deployed without issue.The cds and sgc were removed as a single unit, without resistance.At the back table, the cds was easily removed from the sgc.Upon removal, a scrape was noted, approximately 1 inch from the tip of the cds.A piece of metal was seen, towards the distal end of the sleeve.When the physician touched the metal, it easily came off.There was no adverse patient effect or a clinically significant delay in the procedure.Returned device analysis noted that the soft tip of the sgc was torn; however, all pieces were present.No additional information was provided.

Manufacturer Narrative

Product performance engineering reviewed the incident information provided to abbott vascular, manufacturing records, complaint history for the reported lot and performed analysis of the returned device.All available information was investigated, and the difficulty advancing the clip delivery system (cds) into the steerable guide catheter (sgc) and difficulty retracting the delivery catheter (dc) handle were not confirmed; however, the metal piece with the device and scrape (torn steerable sleeve braided shaft) was confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint identified no similar incidents reported from the lot.The investigation was unable to determine a conclusive cause for the difficult cds insertion and dc handle retraction issue.However, the investigation determined that the reported metal piece with the device and scrape (torn steerable sleeve braided shaft) appears to be related to a potential product issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

Manufacturer Narrative

H11 h6: results code 114-removed.Conclusions code 4315-removed.

• 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: 9269665
• MDR Text Key: 176602631
• Report Number: 2024168-2019-13130
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

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: 06/27/2020
• Device Model Number: CDS0601-NTR
• Device Catalogue Number: CDS0601-NTR
• Device Lot Number: 90627U472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/11/2019; 02/11/2020
• Supplement Dates FDA Received: 11/25/2019; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 135