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

Catalog Number CDS0602-NTR

Device Problem Leak/Splash (1354)

Patient Problem Ischemia (1942)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

The device has been received.Investigation has not yet been completed.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

This is being filed to report during use of the clip delivery system, a leak was noted, and aspiration was performed.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade of 3-4 and massive prolapse of the leaflets.The first clip was implanted without issue and mr was reduced to 1.However, the physician decided to implant a second clip due to the massive prolapse.After insertion of the second clip delivery system (cds) into the steerable guide catheter (sgc), the electrocardiogram (ecg) increased of the st-segment was visible.Air was seen in the steerable guide catheter and aspiration was not possible, only air could be aspirated.The cds was retracted from the sgc and the air could be aspirated and ecg was normalized.All stopcocks were checked and tight.A leak in the sealing of the clip introducer was suspected.The physician decided to abort the case.The mr remained 1 with one clip implanted.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the returned device analysis confirmed the reported leak due to the observed due to the silicone valve tear of the clip introducer (ci).A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted in this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.All available information was investigated and observed torn ci silicone valve appears to be due to procedural circumstances/user technique and is related to operational context.The reported leak was a cascading effect of the silicone valve tear.The reported ischemia appears to be due to the reported leak.The reported unexpected medical intervention appears to be due to case specific circumstance as air was aspirated which normalized the electrocardiogram (ecg).The reported patient effect of transient ischemia attack, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11739958
• MDR Text Key: 247975760
• Report Number: 2024168-2021-03612
• Device Sequence Number: 1
• Product Code: NKM
• 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: 06/11/2021

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: 11/12/2021
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 01110U381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention