MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The two additional devices referenced are filed under separate medwatch report numbers.

Event Description

This is filed to report atrial perforation.It was reported that on (b)(6) 2020, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4.It was noted that the mr was caused by annular dilatation.Two clips (00410u169 and 00410u109) were successfully implanted, reducing mr to a grade of 1.On (b)(6) 2020, the patient presented to the hospital with severe pulmonary edema.Transthoracic echocardiography (tte) showed that mr had increased to a grade of 3 and a left to right atrial shunt was present.On (b)(6) 2020, an additional tte was performed and showed that both clips were stable on the leaflets.At this time, it was also noted that the patient had developed right sided heart failure, increased left atrial pressure and the annular dilatation had worsened.It was noted that the patient diuretics weren't well controlled which led to an overload of volume.Later that day, the patient underwent a second mitraclip procedure to treat mr with a grade of 3.It was noted that prior to the procedure, the mean pressure gradient was 5mmhg.One clip (00401u113) was implanted, reducing mr to a grade of 1.A closured device was then implanted to treat the left to right shunt.However, after the procedure, it was noted that the patients mean pressure gradient increased to 7mmhg.There was no clinically significant delay in the procedure.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information provided, the reported atrial perforation is the result of procedural conditions.The patient effect of atrial perforation is listed in the mitraclip instructions for use (ifu) as 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: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10547466
• MDR Text Key: 207359344
• Report Number: 2024168-2020-07790
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 00623U739
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP (X2); IMPLANTED MITRACLIP (X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR