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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 SENSH2028W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Paralysis (1997); Obstruction/Occlusion (2422); Vascular Dissection (3160)
Event Date 02/25/2021
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 an accessory device with a thoracic visceral manifold stent graft that was implanted in a patient for the endovascular treatment of a 65mm aortic aneurysm. A non mdt 38mm x 150 device was utilized to relign the existing graft per protocol. The non mdt device was deployed with no issue. Ballooning was performed with a non mdt balloon post implant. Following tevar, a 40mm thoracic bifurcate was utilized within the non mdt device and followed by a visceral manifold. Ballooning of the mentioned devices and sma, and both renal arteries were selected out and bypassed via non mdt stents to the manifold limbs. All went with no issue. Later that evening, the physician noted that the patient had no pulse in the left leg as therefore the physician had to stent the left iliac due to dissection. The physician said the probable cause was the sheath being used. All was well after the stenting of the left iliac was performed. It was noted that the patient wasn't moving their legs. They began draining the patients spinal drain and increasing pressure. The visceral manifold was occluded. It was reported the next day that the patient had expired. As per the physician the cause of death was from a massive subarachnoid hemorrhage and paralysis. As per the physician the cause of the events could not be determined. No additional clinical sequelae were provided and the patient is expired.
 
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Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key11562713
MDR Text Key242028048
Report Number9612164-2021-01134
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/20/2022
Device Model NumberSENSH2028W
Device Catalogue NumberSENSH2028W
Device Lot Number00152786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2020
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: 03/24/2021 Patient Sequence Number: 1
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