MAUDE Adverse Event Report: TRANSAORTIC MEDICAL TRANSGLIDE EXPANDABLE INTRODUCER; INTRODUCER CATHETER

Model Number	TA-006
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Collapse (2416)
Date of Event	08/23/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluation: a review of the manufacturing documentation for transglide expandable introducer device (lot #100729) and all of its subassembly components was completed and found that the device met its material, assembly and product specifications at the time of release to distribution.There were no nonconformances that may be related to this reported incident.In addition, a complaint trend review was completed and there were no complaints with relation to this event-type.A review of risk management documents and hazard analysis was completed and confirmed the hazard event and potential patient risks associated with the event were included.Device (ta-006/lot 100729) was returned to transaortic medical on 9/15/2017 from the eu distributor.Device components were assessed and the principal r&d engineer confirmed all device components were acceptable.It was noted that a longitudinal crease was observed on the distal end of sheath assembly.The crease on the distal end of the sheath assembly could potentially be attributed to vessel anatomy/disease, including excessive calcification within the iliac causing the sheath to crease longitudinally during insertion or removal.An evaluation confirmed that the returned device meets product specifications.The probable root cause in this case for the rupture in the right common iliac artery could not be confirmed, however vessel size and condition could have contributed to the event as the physician did not perform a peripheral ct scan prior to the procedure.A coronary angiogram was performed 6 months prior to the procedure.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the physician to determine if the interventional device can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.Despite screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices a review of transglide expandable introducer ifu (instructions for use) was reviewed for pre-cautions and warnings associated with the device.According to the ifu, cardiovascular complications, including iliac perforation, aortic perforation, infection, post-procedural discomfort, air embolism, tissue trauma, hemorrhage, thromboembolism, thrombosis, injury to the vascular introduction site and death are potential adverse events associated with transfemoral transcatheter aortic valve replacement procedure.The ifu and reference material have been reviewed and no inadequacies have been identified with regards to warnings, contraindications and the directions/conditions for the successful use of the device.As a result of the assessment with consideration of the hazard analysis review and risk factors, no further action is required.Transaortic medical will continue to trend complaint rates as applicable.
Event or Problem Description
On sep.4, 2017, transaortic medical received an email from our eu distributor regarding an event that occurred on (b)(6) 2017: our device, the transglide expandable introducer was used during a tavi procedure.During insertion of the sheath, the physician felt a slight resistance but the introducer was able to enter into the vessel without any problem.Upon extracting the transglide, the patient complained of pain.At this moment, pressure levels of the patient dropped and a cardiac massage was performed.Doctors then analyzed via angiography the anatomy of patient and it was noticed that there was a rupture in the right common iliac artery.Immediately, a peripheral balloon was inflated above the lesion to stop the bleeding and the vascular surgeon was called to fix the artery.They put 4 covered stents into the vessel to fix the rupture with a good result.The patient was stable.However, on (b)(6) 2017 (transaortic medical was informed on september 4, 2017), the patient involved in this procedure passed away from retroperitoneal bleeding and global deterioration.Additional information was received from attending physician (dr.(b)(6)): "the pre-tavi study showed a patient with a sinus rhythm in ecg, severe as in echo, with moderate to severe septal hypertrophy.Coronary angio showed no coronary stenosis, and by aortogram, iliac and femoral artery are good for transfemoral approach with diameters from 6 to 7 mm.During the procedure, we make a right femoral puncture, angio-guided from a catheter inserted via left femoral artery (contralateral guidance).A prostar closure device was inserted without problem.The transglide mesh assembly crosses the femoral and the iliac artery easily, without any friction.A 20f sheath (transglide sheath assembly) was inserted, but, with several difficulties, so i had to make some effort to put this sheath in place, but at this moment the patient was ok.We performed the tavi procedures without difficulties.After checking an excellent result of the tavi, we retrieve the 20f mesh + sheath(transglide), at this time with extreme difficulty, and a big traction was needed to retrieve it.At this time, a severe drop in the arterial pressure was noticed, and the patient collapsed.A very big iliac perforation was noticed by angio, and several efforts to close this perforation were done, with implantation of 4 covered stent, solving the complication.But unfortunately, 4 days after the procedure, the patient died due to retroperitoneal bleeding and global deterioration.".

• Brand Name: TRANSGLIDE EXPANDABLE INTRODUCER
• Common Device Name: INTRODUCER CATHETER
• Manufacturer (Section D): TRANSAORTIC MEDICAL; 135 e. main ave. suite 170; morgan hill CA 95037
• MDR Report Key: 6905612
• Report Number: 3011065569-2017-00001
• Device Sequence Number: 862027
• Product Code: DYB
• UDI-Device Identifier: 00866697000224
• UDI-Public: 00866697000224
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: TA-006
• Device Catalogue Number: TA-006
• Device Lot Number: 100729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2017
• Initial Report FDA Received Date: 09/29/2017
• 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: Death; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 58