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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
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.
 
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Brand NameSTEERABLE GUIDE CATHETER
Type of DeviceVALVE 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 Key8870039
MDR Text Key153558690
Report Number2024168-2019-10637
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
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 Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/11/2020
Device Catalogue NumberSGC0303
Device Lot Number90111U131
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 Received01/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/11/2019
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
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