• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number SENSH1628W
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Dyspnea (1816); Myocardial Infarction (1969); Insufficient Information (4580)
Event Date 08/18/2022
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: section d information references the main component of the system. Other relevant device(s) are: other relevant devices are: sensh1228w, s/n; unknown use by date: unknown; upn # unknown. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
An endurant stent graft system was implanted during de novo procedure. Two sentrant sheath and three reliant balloons were also used in the procedure.   it was reported that the patient presented emergently with increased shortness of breath. Patient was admitted with acute exacerbation of congestive heart failure. Upon further review nstemi was diagnosed. Blood transfusion , medication, bi-pap and intubation were performed. The patient expired 3 days later.   the site assessed the event as not related to the study procedure. The sponsor assessed the event as possibly related to the index study procedure since event occurred less than 30 days from index procedure.   no additional clinical sequelae was provided and the patient has expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key15318598
MDR Text Key298855756
Report Number9612164-2022-03214
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 Study,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSENSH1628W
Device Catalogue NumberSENSH1628W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/30/2022 Patient Sequence Number: 1
-
-