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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

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AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER Back to Search Results
Catalog Number SGC0301
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Heart Failure (2206); Cardiogenic Shock (2262); Atrial Perforation (2511)
Event Date 10/18/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this incident. The reported patient effects of dyspnea, renal failure, worsening heart failure, cardiogenic shock and atrial septal defect (atrial perforation) are listed in the electronic mitraclip system instructions for use as known possible complications associated with mitraclip procedures. Based on the information reviewed, the reported patient effect of atrial septal defect (asd) appears to be related to procedural conditions, as the steerable guide catheter (sgc) was advanced through the septum in order to gain access to the left atrium for positioning. Additionally, the patient effects of shortness of breath (dyspnea), weakness, renal failure, cardiogenic shock and heart failure were due to asd. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the previously filed 30-day medwatch report, the following information was provided: on (b)(6) 2017, the patient was readmitted into the hospital with shortness of breath and weakness. The patient had right heart failure, pericardial effusion and renal failure which were not present at the time of discharge during the initial procedure. On (b)(6) 2017, echocardiogram was performed and a pericardial effusion was noted. No treatment was performed. On (b)(6) 2017, the atrial septal defect (asd) was closed and the patient was extubated and stable. In the physicians opinion, the patients symptoms and shock were from the mr increase due to the slda and the asd. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The customer reported the steerable guide catheter was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The implanted clip is filed under a separate medwatch report number.
 
Event Description
This is filed to report the atrial septal defect (asd). It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. One clip was implanted without issue. The second clip delivery system (cds) was advanced to the mitral valve and the clip was deployed. An attempt was made to remove the gripper line, but the line could not be removed. The gripper line was attempted to be removed for 45 minutes. At this point, the cds and steerable guide catheter (sgc) were removed. The two ends of the gripper line were cut at the skin, leaving the remaining portion of line in the anatomy. The patient was confirmed to be stable and no further treatment was performed. The mr was reduced to 2. On an unspecified date, the patient was readmitted into the hospital, symptomatic. Angiography was performed, and it was found that the clip with the gripper line attached had detached from the anterior leaflet and remained attached to the posterior leaflet (slda). The mr had increased to 4+. A new mitraclip procedure was planned for treatment; however, the patient was in heart failure and kidney failure, so that was no longer an option. On (b)(6) 2017, the asd was closed off due to the heart failure which was causing the patient to be in shock. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceSTEERABLE GUIDE CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key7021023
MDR Text Key109287479
Report Number2024168-2017-08875
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 company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/27/2018
Device Catalogue NumberSGC0301
Device Lot Number70726U131
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 Received11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2017
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: 11/10/2017 Patient Sequence Number: 1
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