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

Catalog Number SGC0303

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

Patient Problems Tricuspid Regurgitation (2112); Atrial Perforation (2511)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Exemption number (b)(4) -permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period.

Event Description

This report is filed due to an atrial septal defect, requiring intervention. Patient id: (b)(6). It was reported that on (b)(6) 2019, the patient presented with mitral regurgitation and was in poor cardiac condition with severe heart failure. There was mild posterior leaflet restriction and difficult visualization due to patient anatomy. One mitraclip (cds0503 ) was unable to grasp and capture the leaflets. There was slight difficulty grasping and most issues were with leaflet capture (before any deployment). The undeployed device was removed without reported issue. Per physician, the difficulty with grasping and leaflet capture did not result in an adverse event. Two mitraclips (cds0601-xtr and ntr) were implanted without issues. The mr had been reduced to grade 2+. That same day, (b)(6) 2019, an atrial septal defect (asd) was observed as evident by pulmonary artery readings of oxygen saturation 74% and internal jugular vein oxygen saturation of 46%. Medication was provided as treatment. On (b)(6) 2019, the patient's central venous pressure (cvp) was elevated with a reduced cardiac output. Cardiogenic shock was diagnosed and medication was provided. Per physician, the shock was due to the patient's pre-existing poor cardiac condition and was unrelated to the implanted mitraclips and unrelated to the sgc. On (b)(6) 2019, due to the patient's pre-existing condition, a left ventricular assist device (lvad) was implanted. To place the lvad, the implanted mitraclips were removed. The clips had remained stable and well seated without any suspected or confirmed tissue damage. The asd was surgically closed. Reportedly, the (b)(6) 2019 elevated cvp, cardiogenic shock, and the (b)(6) 2019 procedure with mitraclip removal due to lvad placement were unrelated to the mitraclips. The sgc had not caused or contributed to the cardiogenic shock requiring lvad placement. There was no reported device malfunction regarding the implanted clips nor a device malfunction with the sgc. No additional information was provided regarding this issue.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• 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: 8870039
• MDR Text Key: 153558690
• Report Number: 2024168-2019-10637
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/11/2020
• Device Catalogue Number: SGC0303
• Device Lot Number: 90111U131
• 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: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• 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: 08/07/2019 Patient Sequence Number: 1

Treatment

3 CLIP DELIVERY SYSTEMS