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

Model Number SENSH2028W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Liver Laceration(s) (1955); Cardiac Tamponade (2226); Obstruction/Occlusion (2422)

Event Date 02/09/2022

Event Type  Death  

Event Description

Two sentrant sheaths were used as a conduit during a medtronic valve implant.It was reported during the index procedure that the patient had multiple complications during the procedure.When the delivery system was removed, right femoral occlusion was observed.After closure with percoles, without lacerations or bleeding, a covered stent was implanted with excellent results.The patient was stable at the end of the procedure.It was reported that in the icu, after 2 hours after leaving the room with, the patient developed hypotension and was diagnosed with cardiac tamponade.An urgent pericardiocentesis was performed, and another bleed was identified in the puncture attempt.The patient was referred to the operating room, where a sternotomy and exploratory laparotomy were performed.Multiple lacerations were identified in the liver as the cause of the bleeding.On the day after the index procedure, the patient progressed to death.Per physician, the cause of death was due to hemorrhagic shock.No additional clinical sequelae was reported and the patient expired.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: sensh1628w, serial/lot #: (b)(4), ubd: 24-may-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, 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 Key: 13706645
• MDR Text Key: 286834075
• Report Number: 9612164-2022-00922
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169792616
• UDI-Public: 00643169792616
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00157734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 65 KG