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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER

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MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number SENSH1428W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hematoma (1884); Perforation of Vessels (2135); Blood Loss (2597); Multiple Organ Failure (3261)
Event Date 08/18/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A sentrant sheath was used as a conduit for a medtronic bioprosthetic valve. Vessel access was noted as thin and tender. It was reported during the index procedure the physician had to switch back and forth between the 14 fr sentrant sheath and a non mdt delivery catheter system in order to implant the valve. The valve was successfully implanted, however at the end of the procedure, a rupture in the external iliac artery occurred. The damaged vessel was attempted to be repaired using a balloon but was unsuccessful, and a stent was implanted to resolve the bleeding. It was reported that the implant procedure and subsequent vessel repair had extended the procedure time resulting in a peritoneal hematoma. The physician taking into account the patients poor clinical status decided not to complete open surgery. Two days following the valve implant, the patient died due to multiple organ failure. Per the physician the cause of the event was anatomy related and the death resulting from vessel complications leading to blood loss and eventual multiorgan failure.
 
Manufacturer Narrative
Film evaluation summary: the reported iliac vessel rupture was confirmed on the films provided; however the cause of the event could not be determined. Analysis of the angiograms received did not show any issues with the sentrant sheath or allow determination of its relatedness to the rupture event. Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant iliac vessel anatomy. It is likely that, as per the physician, the patient¿s vessel anatomy may have been a contributory factor in the occurrence of the vessel rupture and subsequent deterioration in the patient¿s condition and death. The sheath was discarded; therefore, a comprehensive analysis of the device could not be performed. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key10487242
MDR Text Key205460189
Report Number9612164-2020-03314
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/20/2021
Device Model NumberSENSH1428W
Device Catalogue NumberSENSH1428W
Device Lot Number00151113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2020
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: 09/03/2020 Patient Sequence Number: 1
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