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

Model Number SENSH2028W

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Intimal Dissection (1333); Death (1802)

Event Date 04/11/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

A 20f sentrant sheath was used as an accessory device for the implant of a 26 evolut pro.  it was reported that due to angulation of the left femoral artery (fa) and small puncture site at the right fa, a surgical cut down on the right fa was performed, distal to the puncture site.After access, insertion of the 20f sentrant sheath was attempted, but was unsuccessful.The sheath could not be inserted higher than proximal to the bifurcation of the two femoral arteries.To retain hemostasis, a 14f introducer was successfully inserted higher than the bifurcation point.The evolut pro delivery system was then directly inserted into the vessel.It was reported that remarkable push was needed to guide the delivery system up to the aortic arch.After successful implant of the evolut pro and removal of the delivery system, the physician noted a heavy dissection of the femoral artery, distal to the access site.Surgery to close the dissection was performed, however this was unsuccessful and the patient expired due to strong unrecoverable arterial bleeding.Per the physician the cause of the event was related to the age of the anatomy.No additional clinical sequelae were reported, the patient is deceased.

Manufacturer Narrative

Film evaluation summary: the exact cause of the reported positioning difficulties, the inability of the sheath to be positioned higher than proximal to the bifurcation of the two femoral arteries, could not be determined from the pre-implant film report provided.The cause of the reported dissection of the right femoral artery distal to the access site, also could not be determined from the films provided.Films during implant were not available for review and the reported events could not be assessed.It is unclear if the sheath positioning difficulties and advancement of the evolut pro delivery system may have contributed to the dissection.It appears that the patients challenging and diseased access vessel anatomy, with calcified and small caliber vessels, was the most likely contributor to the events which appear to have led to the patient¿s death.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: 8526486
• MDR Text Key: 142319624
• Report Number: 2953200-2019-00525
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/22/2019

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
• Device Operator: No Information
• Device Expiration Date: 09/14/2019
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00134323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 04/29/2019
• Supplement Dates FDA Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/14/2018
• 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; Required Intervention
• Patient Age: 96 YR