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

Catalog Number SGC0704

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

Patient Problem Perforation (2001)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it was reportedly discarded. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The mitraclips, are filed under separate medwatch report numbers.

Event Description

This report is being filed due to a clinically significant atrial septal defect requiring surgical intervention. Patient id: (b)(6). It was reported that on (b)(6) 2021, a mitraclip procedure was performed to treat degenerative mitral regurgitation (dmr) grade of 4+ with p2 leaflet prolapse and a p2 flail. The p2 leaflet was redundant. Two xtw mitraclips were delivered and deployed on the a2p2 leaflets. Reportedly, both these clips rotated after deployment, while remaining stable on the leaflets. An ntw mitraclip advanced to the mitral valve with noted difficult visualization due to the anatomy and anatomy being so commissural. The mitraclip was having difficulty grasping the leaflets and was unable to capture leaflets. It was decided to remove this clip. During cds removal, some resistance was met with the anatomy. Standard troubleshooting was performed with successful removal following. Reportedly, during the removal, chordal rupture was possible as there was new flail or anterior prolapse that was not present before the procedure. Another xtw mitraclip was successfully delivered and deployed on the a1p1 leaflets. This clip was the most lateral clip. There was no detachment observed post the index procedure. The mr was reduced to 1-2+. There was no clinically significant delay in the procedure. There was no device issue or malfunction regarding the implanted xtw clips. On (b)(6) 2021 the patient was readmitted to the hospital due to dyspnea, chest tightness, and worsening heart failure was diagnosed. Medications had been provided as treatment. Per imaging, severe mr, mitral stenosis, and chordal damage were observed. The pulmonary artery (pa) pressures were noted elevated. Reportedly, there was no concern regarding the implanted xtw mitraclips. These clips had remained well seated without any device malfunction. However, per physician, there was a flail chord or flail leaflet at the a1p1 area that was not identified during or after the initial procedure. The a1 had torn off the annulus from the most lateral clip. This clip was subvalvular. The physician believes that the patient "popped a chord" causing the severe mr to return. The popped chordae associated with the third clip was that one of the chordae tore off the sub-valvular area and a new flail was noted in the atrium due to this. The chordae was still attached to the ventricular area. On (b)(6) 2021 the three mitraclips were successfully explanted and valve replacement was performed as treatment. An atrial septal defect closure, tricuspid repair, and left atrial appendage ligation were also performed. Non-abbott physio rings were placed in the valves. The mr had been reduced to grade 1+. Reportedly, the tricuspid repair was unrelated to the mitraclip devices and unrelated to the mitraclip procedure. No additional information was provided regarding this issue.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12499915
• MDR Text Key: 273552509
• Report Number: 2024168-2021-08308
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/10/2021
• Device Catalogue Number: SGC0704
• Device Lot Number: 01110U134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/20/2021 Patient Sequence Number: 1