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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 Difficult or Delayed Positioning (1157)
Patient Problems Stroke/CVA (1770); Paralysis (1997); Perforation of Vessels (2135)
Event Date 05/22/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A valiant captivia stent graft system was intended for implant in a patient for the endovascular treatment of a 14 mm thoracic aortic pau. The diameter of the aorta at the pau was 42 mm. The patient had a previous evar with an endurant device on an unknown date. It was reported that during the index procedure, the physician first tried to gain access via the right side, but it was occluded. They then accessed the left common femoral, which was narrow. The physician used a non-medtronic pta 7 x 60 mm non-compliant balloon. The physician then attempted to advance the valiant captivia percutaneously via the access vessel, but it did not advance. The physician then implanted two 8 x 59 mm non-medtronic and one 8 x 39 mm, and advanced an 18 fr non-medtronic dilator through the stents. An attempt was then made to advance a 20 fr sentrant dilator through the distal non-medtronic stent, but it did not advance. The physician then inflated a 9 mm non-medtronic balloon in the 3 stents. They then attempted to advance the 18 fr non-medtronic sheath, but it did not advance. An angiogram was then performed, and it was observed that the distal leia was ruptured and there was extravasation outside of the vessel. The physician then extended the distal non-medtronic stent with another 8 x 39 mm and performed another angiogram. There was still a leak and the patient's blood pressure had dropped. They placed an 8 x 38 over the junction of the two 8 x 59 mm stents, resolving the leak. The patient's blood pressure then stabilized. At that time the physician aborted the procedure and closed the three perclose devices in the left groin. Upon completion of the procedure, it was determined that there was no pulse in the patient's left foot. The physician opened the right groin and fixed the occlusion to restore bloodflow by reconstructing the leia and lcfa. After the patient was transferred to the pacu, it was then determined that they had suffered a stroke on their left side and were unable to move their left arm or leg. After determining that there was no pulse present in the left foot, the physician returned the patient to the or and put tpa in their leg to dissolve the clot in the left foot and restore blood flow. The following day, the patient was able to move their left foot. Per the physician, the cause of the event was due to the attempts to gain access for the sheaths. No additional clinical sequelae were reported and the patient will be monitored by their physician.
 
Manufacturer Narrative
Additional information received: the patient's anatomy was not noted as tortuous. The cause of the event was given as trying to advance the non mdt sheath. 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 CA
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie CA
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
091708096
MDR Report Key8666600
MDR Text Key146923368
Report Number9612164-2019-02151
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 07/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/11/2019
Device Model NumberSENSH2028W
Device Catalogue NumberSENSH2028W
Device Lot Number00134562
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 Received06/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/11/2018
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: 06/04/2019 Patient Sequence Number: 1
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