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

Model Number SENSH1428W

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

Patient Problems Death (1802); Hematoma (1884); Perforation of Vessels (2135); Blood Loss (2597); Multiple Organ Failure (3261)

Event Date 08/18/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A sentrant sheath was used as a conduit for a medtronic bioprosthetic valve.Vessel access was noted as thin and tender.It was reported during the index procedure the physician had to switch back and forth between the 14 fr sentrant sheath and a non mdt delivery catheter system in order to implant the valve.The valve was successfully implanted, however at the end of the procedure, a rupture in the external iliac artery occurred.The damaged vessel was attempted to be repaired using a balloon but was unsuccessful, and a stent was implanted to resolve the bleeding.It was reported that the implant procedure and subsequent vessel repair had extended the procedure time resulting in a peritoneal hematoma.The physician taking into account the patients poor clinical status decided not to complete open surgery.Two days following the valve implant, the patient died due to multiple organ failure.Per the physician the cause of the event was anatomy related and the death resulting from vessel complications leading to blood loss and eventual multiorgan failure.

Manufacturer Narrative

Film evaluation summary: the reported iliac vessel rupture was confirmed on the films provided; however the cause of the event could not be determined.Analysis of the angiograms received did not show any issues with the sentrant sheath or allow determination of its relatedness to the rupture event.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant iliac vessel anatomy.It is likely that, as per the physician, the patient¿s vessel anatomy may have been a contributory factor in the occurrence of the vessel rupture and subsequent deterioration in the patient¿s condition and death.The sheath was discarded; therefore, a comprehensive analysis of the device could not be performed.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 10487242
• MDR Text Key: 205460189
• Report Number: 9612164-2020-03314
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2021
• Device Model Number: SENSH1428W
• Device Catalogue Number: SENSH1428W
• Device Lot Number: 00151113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2020
• 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: 84 YR