MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA SENTRANT INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number SENSH2228W

Device Problems Break (1069); Difficult to Insert (1316); Device Damaged by Another Device (2915)

Patient Problem Death (1802)

Event Date 07/10/2017

Event Type  Death  

Manufacturer Narrative

Failure to follow instructions - use of the undersized sentrant sheath.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A sentrant sheath was used in a patient for the endovascular treatment of a thoracic aortic aneurysm.It was reported that another manufacturer¿s stent graft was implanted the patient using a sentrant sheath.A 22 fr sheath was inserted in to a previously placed abdominal y-shaped stent graft, the limb of which measured 8mm.It was noted that resistance was felt when crossing this area.It was also noted that this was an off-label use of the sheath.The first of two stent grafts from another manufacture were then inserted into the sheath.The first was delivered with resistance but was implanted normally.The second stent graft also encountered resistance and could not be fully deployed.It was partially deployed.Ballooning was attempted but was unsuccessful.The device could not be withdrawn so the patient was converted to a thoracotomy.The patient was opened and the physician noted that the coil braid of the sentrant device was entangled with the other manufacturer¿s stent, which prevented it from deploying.A vessel prosthesis was implanted and the incision was closed.After a few hours in the icu the patient expired.The physician stated that the patient was advanced in age and in poor condition and it was possible that they were unable to survive this long treatment and invasion due to thoracotomy.The physician further stated that the event was caused by user error and that the event was a result of the device being used out of indication.It was noted that, although the cause of the damage to the sentrant was not clarified, detachment of the sentrant¿s coil braid could have been attributed to the off-label use of the undersized sentrant and the resistance noted at the 8mm y-graft leg.No additional clinical sequelae were reported.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer (Section G): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6756268
• MDR Text Key: 81462142
• Report Number: 2953200-2017-01199
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169150355
• UDI-Public: 00643169150355
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2018
• Device Model Number: SENSH2228W
• Device Catalogue Number: SENSH2228W
• Device Lot Number: 00120820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• Date Device Manufactured: 02/16/2017
• 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