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

Model Number	SENSH2028W
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Stroke/CVA (1770); Paralysis (1997); Perforation of Vessels (2135)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie CA
• MDR Report Key: 8666600
• Report Number: 9612164-2019-02151
• Device Sequence Number: 2257726
• Product Code: DYB
• UDI-Device Identifier: 00643169792616
• UDI-Public: 00643169792616
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/11/2019
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00134562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 66 YR