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Model Number 9610ES16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Vascular Problem (4441)
Event Date 08/11/2022
Event Type  Injury  
Event Description
As reported, it was a case of a 29mm sapien 3 valve, on aortic position by transfemoral approach. After the esheath removal, the closure device failed. The bleeding increased and wash out from endothelial tissue of the puncture site. A 18fr non-ew sheath was inserted to stop the bleeding. The vascular surgeon saw a crack in arteria femoralis that extended to cranial in direction of arteria iliaca externa. An end to end anastomosis was performed on the part of arteria femoralis with a good result. Angiographically was also performed with good result. The esheath was in its best condition and without visible damage.
Manufacturer Narrative
Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention. According to the literature review, and as documented in a technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities. Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications. Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur. The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications. The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed. It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices. The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity. Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally. Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters. The operators are trained to measure minimum vessel diameter taking calcium into account. The physician training manual also lists the minimum recommended vessel size for each size device. Despite the best 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. In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size. In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event. The minimum required vessel diameter for an 16 fr sheath is 6. 0 mm. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. Per the instructions for use (ifu), cardiovascular injury is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices. In this case, there was no allegation or indication a product malfunction contributed to this adverse event. Investigation results suggest the failing of the closure device and the crack in arteria femoralis that extended to cranial in direction of arteria iliaca externa caused or contributed to this event. A review of edwards lifesciences risk management documentation was performed for this case. The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time. The ifu and training manuals 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. Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review. No corrective or preventative actions are required. The device is not returning.
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Manufacturer (Section D)
1 edwards way
irvine CA 92614
Manufacturer (Section G)
1 edwards way
irvine CA 92614
Manufacturer Contact
renee van dorne
1 edwards way
irvine, CA 92614
MDR Report Key15330931
MDR Text Key299041541
Report Number2015691-2022-07639
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9610ES16
Device Lot Number64240726
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2022 Patient Sequence Number: 1