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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 SGC0302
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Tricuspid Regurgitation (2112); Heart Failure (2206); Atrial Perforation (2511)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed for atrial septal defect resulting in increased heart failure. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. Two clips were implanted and the mr was reduced to grade 2+. On (b)(6) 2018, the patient was re-hospitalized. The right to left atrial shunt was increased, resulting in increased heart failure and pulmonary hypertension. The mr remained unchanged. Moderate tricuspid regurgitation was noted. Medication was administered. No additional information was provided.
 
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. Based on the information reviewed, there is no indication of a product quality issue. The reported patient effects of hypertension, heart failure, cardiac perforation (atrial perforation) as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures. Based on this information, the reported patient effect of atrial perforation appears to be related due to procedural circumstances. Reported patient effects of hypertension, heart failure and tricuspid regurgitation appears to be the cascading effects caused due to atrial perforation. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial report filed, additional information was received: the right to left shunt was due to the iatrogenic atrial septal defect (asd) from the mitraclip procedure. Moderate tricuspid regurgitation was related to the asd. The mitraclips were noted to be well attached to both leaflets. No intervention was performed to seal the asd. Medication was administered to treat the heart failure and hypertension. 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 Key7911003
MDR Text Key121775780
Report Number2024168-2018-07418
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/05/2019
Device Catalogue NumberSGC0302
Device Lot Number80205U124
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 Received11/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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: 09/26/2018 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIPS (X2)
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