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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM

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AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0201
Event Date 09/29/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Internal file number -(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. Date of event, date of implant - estimated. Due to system limitations, the type of report is selected as 30-day although this is a periodic report. Pas1 and pas2 mitraclip post approval study data is reported as a summary per summary reporting exception approval number (b)(4). The devices are not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

 
Event Description

Per the requirements of the post approval study 1 (pas1) and pas2, post approval mitraclip studies conducted via the tvt registry, abbott has received data downloaded from the center for medicare and medicaid services (cms) claims database for patients in the studies. The data contained 1014 adverse events. The relationship of the events to the mitraclip device cannot be determined based on the data received; therefore, abbott vascular is conservatively reporting these events. The data is reported as a summary report per summary reporting exemption approval number (b)(4).

 
Manufacturer Narrative

(b)(4). The device was not returned for analysis. Additionally, a review of the lot history records could not be conducted, because the lot numbers were not provided. The reported patient effects of atrial fibrillation, myocardial infarction, transient ischemic attack (tia) and worsening heart failure, are listed in the mitraclip system electronic instructions for use as known possible complications associated with mitraclip procedures. Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design, or labeling.

 
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Brand NameMITRACLIP SYSTEM CLIP DELIVERY SYSTEM
Type of DeviceMITRACLIP DELIVERY SYSTEM
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 Key7211247
Report Number2024168-2018-00519
Device Sequence Number1
Product CodeNKM
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Report Date 02/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCDS0201
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 Received02/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/22/2018 Patient Sequence Number: 1
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