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

MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA 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 CARDIOVASCULAR SANTA ROSA 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 Perforation of Vessels (2135); Rupture (2208); Vascular Dissection (3160)
Event Date 05/19/2022
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Valiant captivia stent grafts were implanted for the endovascular treatment of a 65mm thoracic aortic aneurysm on the (b)(6) 2022. The procedure which was carried out percutaneously as per physicians choice. It was noted this patient is undergoing a 2 stage procedure due to the complex anatomy and will come back for a planned second stage of her repair. It was reported during the index, the physician started off with running the 20 french dilator up the iliac which it passed with no issues.  the 3 valiant captivia devices went up and deployed with no issues. Upon completion a retrograde angiography of the left iliac system was taken and it was found that the distal common iliac had a small dissection. The physician finished the taa portion of the procedure by working on the left subclavian. After the left subclavian was finished, the physician went back to address the left common iliac. When pulling the 20 french sheath back, the physician felt something give. A retrograde angiograph was performed showing the external iliac was transected 4 non-mdt stents were implanted to control the bleeding. The patient remained stable the entire procedure and blood pressure did not drop. The left internal was covered during the stent placement. The physician performed a cutdown to close the groin to make sure the patient had no additional bleeding and the patients condition was reported as doing well post op with plans for discharge home. As per the physician it is believed the cause of the dissection and transected iliac was as a result of the left external iliac spasming down on the sheath and when the sheath was pulled back it transected the left external iliac.   no additional clinical sequelae was provided and the patient is fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSENTRANT INTRODUCER SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC CARDIOVASCULAR SANTA ROSA
3576 unocal place
santa rosa CA 95403
Manufacturer (Section G)
MEDTRONIC CARDIOVASCULAR SANTA ROSA
3576 unocal place
santa rosa CA 95403
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key14562435
MDR Text Key293066251
Report Number2953200-2022-00011
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSENSH2028W
Device Catalogue NumberSENSH2028W
Device Lot Number00165388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2022
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: 06/01/2022 Patient Sequence Number: 1
-
-