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

Catalog Number CDS0502

Device Problems Leak/Splash (1354); Unstable (1667)

Patient Problem Air Embolism (1697)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

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 is filed under a separate medwatch report number.

Event Description

This is filed to report air embolism.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.The steerable guide catheter (sgc) was advanced and when inserting the clip delivery system (cds), the three-way stopcock of the clip introducer was observed to be opening and the sgc had loss of fluid column.The physician immediately closed the three-way stopcock and aspirated.The air calmed down, but when advancing the cds, new air bubbles appeared in the left atrium; therefore, the physician decided to remove the sgc and cds.The procedure continued, one clip was implanted, reducing mr to 1.The physician confirmed that there was no symptom of cerebral infarction in the patient after surgery.It could not be confirmed what device contributed to the air.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak and unstable could not be 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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported leak and unstable stopcock.The air embolism appears to be an outcome of the leak.The reported patient effects of air embolism, as listed in the mitraclip nt system (ifu), is a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10289051
• MDR Text Key: 199271389
• Report Number: 2024168-2020-05924
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2020
• Device Catalogue Number: CDS0502
• Device Lot Number: 91007U178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 08/27/2020
• 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; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 36