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

Model Number	SENSH2428W
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/18/2018
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
Implantation of a valiant captiva stent graft system was attempted in a patient for the endovascular treatment of a 60mm diameter thoracic aortic aneurysm.Severe calcification was present, and the vessel diameter was approx.8mm.It was reported that during the index procedure, the valiant device was advanced through the sentrant sheath, but could not reach the lesion.It was noted that the strain relief was cut to insert the device delivery system but this also failed.Delivery was attempted a second time, without the use of a sheath, but was unsuccessful as the access vessel was damaged.The physician then attempted to advance the device in the contralateral artery, however this also failed, and the procedure was aborted.It was also reported that the valiant delivery system was difficult to insert through the sentrant sheath.After several attempts the device was successfully inserted, however the coating of the valiant stent graft was reportedly removed.The physician also noted an abnormality with the valve of the sheath and the valiant device during delivery.The physician commented that the device did not deliver as normal and this may have been related to the removal of the stent graft coating or due to the delivery system damage.Per the physician, the cause of the event was anatomy related, severe calcification present.No additional clinical sequelae were reported, and the patient will be monitored by their physician.Outcome attributed to adverse event: procedure was abandoned.
Additional Manufacturer Narrative
Film evaluation summary: a single 3d-ct reconstruction image from an unknown study date was returned.No scale was seen on the films; therefore, no stent graft or vessel measurements could be performed.The taa was seen just caudal to the lsa.The access vessels including the iliac arteries were extensively calcified bilaterally, and both common iliacs were moderately tortuous; especially on the right side.The abdominal aorta was essentially straight; however, the thoracic aorta was severely angulated in two locations.Within the descending thoracic the aorta was acutely angulated ~105deg and the flow lumen appeared narrowed at this acute bend, and acute angulation was also seen at the arch just distal to the taa.The thoracic was calcified along the majority of its length.The exact cause of the delivery system positioning difficulties (inability to reach the lesion from either side), and the reported a ccess vessel damage, could not be determined from the single returned pre-implant image.Complete ct¿s prior to implant were not available for a more complete anatomical assessment, and images during implant showing the reported events were also not provided.It is likely that the patient¿s severely calcified and tortuous anatomy may have contributed.Multiple insertion attempts may have also led to the reported removal of the delivery system hydrocoating, as well as the difficulty to insert the device through the sentrant sheath.The cause of the reported abnormality with the sheath valve also could not be determined.
Additional Manufacturer Narrative
Device evaluation summary: device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The device returned with the procedural sheath.The strain relief had been cut away.The device was loaded into the procedural sheath with no issues noted.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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
• MDR Report Key: 7262821
• Report Number: 2953200-2018-00203
• Device Sequence Number: 1222917
• Product Code: DYB
• UDI-Device Identifier: 00643169150362
• UDI-Public: 00643169150362
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2018

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: Health Professional
• Device Expiration Date: 07/10/2018
• Device Model Number: SENSH2428W
• Device Catalogue Number: SENSH2428W
• Device Lot Number: 00124947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 02/12/2018; 06/14/2018; 08/08/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 03/06/2018; 07/10/2018; 10/03/2018
• 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: Other
• Patient Age: 69 YR