MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS EXPANDABLE INTRODUCER SHEATH, 18R; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 918ES26

Device Problems Material Frayed (1262); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2015

Event Type  malfunction  

Manufacturer Narrative

The expandable sheath was returned for evaluation.During visual inspection, the distal tip was damaged, majority of the sheath liner was unexpanded; however, approximately 0.5 inches of the liner at the distal tip was expanded.No dimensional or functional testing was performed due to the condition of the returned device (sheath tip opened and expanded).The sheaths undergo multiple 200% inspections during manufacturing.These inspections support a conclusion that it is unlikely a manufacturing non-conformance was the cause of the complaint.The complaint was confirmed, however, no manufacturing non-conformances were identified.As reported, the physicians felt that the incision was not big enough to accommodate the insertion of the sheath.¿ these factors along with any local concentrations of calcification and/or tortuosity not appreciable on pre-procedural imaging can contribute to such issues.Available information suggests that patient/procedural factors (vessel calcification/tortuosity, size of incision site) may have contributed to the event.The ifu and the thv training manual instructs on procedural considerations for sheath insertion with regards to proper screening and contraindications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators.It also notes that calcification may reduce lumen diameter and limit or prevent transfemoral passage of the devices.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.Per report, the physicians felt that the incision was not big enough to accommodate the insertion of the sheath.The sheath could have been getting caught on the incision (skin).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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.Method: (b)(4); manufacturing review.Result: (b)(4): operational problem.Conclusion: (b)(4): human factors.

Event Description

During a transfemoral procedure, the 18fr esheath could not be advanced into the patient.It appeared that sheath could not be inserted past the incision.After removing the esheath a "flap" at the end of the seam was noted.There was no injury to the patient.A new esheath was inserted and the procedure was completed.Two dilators a 16fr and 18fr were inserted without any difficulty.The patient's access vessel minimum luminal diameter (mld) was measured at 7.0mm.The vessel was mildly calcified and no tortuosity was reported.As per report, the physicians felt that the incision was not big enough to accommodate the insertion of the sheath; the sheath could have been getting caught on the incision (skin).

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH, 18R
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5005231
• MDR Text Key: 23118235
• Report Number: 2015691-2015-02064
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: 918ES26
• Device Lot Number: 59725574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• 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 Age: 79 YR