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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 Problem Cardiac Arrest (1762)
Event Date 09/10/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 to report the patient death. It was reported that this was a mitraclip procedure to treat grade 3-4 functional mitral regurgitation (mr). Acute procedural success was achieved with the implantation of one mitraclip reducing mr to grade 1. It was then noted that the iliac vein ruptured. Treatment was performed with an occlusion balloon and a stent graft. The bleed appeared to have stopped. After the sheath was withdrawn, the blood pressure dropped and the patient went into cardiac arrest. Cardiopulmonary resuscitation was performed and pcps (percutaneous cardiopulmonary support) was inserted. The iliac vein was still bleeding. A long stent graft was implanted. Sinus rhythm returned, but the blood pressure was unstable. The patient was brought to the intensive care unit with pcps. In the opinion of the physician, when the 16 french sheath was inserted, resistance was met and insertion was done with excessive force, causing the iliac vein rupture. There were no device performance issues with the mitraclip. One day post procedure, the patient expired. Autopsy identified the cause of death as hematothorax due to cardiac massage. 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. The reported patient effect of cardiac arrest appears to be the secondary effect of the iliac vein rupture and hemorrhage. The patient death was a consequence of the hemothorax. The reported patient effects of cardiac arrest and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key7918599
MDR Text Key122031822
Report Number2024168-2018-07500
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 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/24/2019
Device Catalogue NumberSGC0302
Device Lot Number80523U228
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 Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2018
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: 09/28/2018 Patient Sequence Number: 1
Treatment
MITRACLIP
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