MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number SGC0301

Device Problem Difficult to Advance (2920)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report tissue damage, hemorrhage and a fistula.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted, but the physician felt resistance during advancement.The sgc was able to reach the left atrium; therefore, the clip delivery system (cds) was inserted.The clip was successfully deployed, reducing mr to a grade of 1.While removing the devices, a cut on the artery was observed, causing a bleed.The physician stated that during insertion, the sgc may have scraped an artery, causing a fistula.However, this was unable to be confirmed.The bleed was successfully treated with a balloon, and the patient was noted to be stable.No additional information was provided.

Manufacturer Narrative

The device was not returned.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, a cause for the reported difficult advancement could not be determined.The reported tissue damage resulting in the fistula and hemorrhage appear to be due to procedural circumstances.The reported medical intervention was a result of case specific circumstances.The reported patient effect of tissue damage, fistula and hemorrhage are listed in the mitraclip system instructions for use as known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11454443
• MDR Text Key: 238921578
• Report Number: 2024168-2021-01904
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 05/11/2021

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: 06/23/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00622U237
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 62