MAUDE Adverse Event Report: EDWARDS LIFESCIENCES 16FR EDWARDS EXPANDABLE SHEATH; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 916ES23

Device Problem Physical Resistance (2578)

Patient Problem Vascular Dissection (3160)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our affiliates in (b)(6), during implant of a 23 mm sapien xt valve in aortic position via transfemoral approach, some additional force was required in order to advance the delivery system through the esheath.The valve was implanted successfully.However, after closing the access site the patient¿s pulse was noted to be weaker.A mild dissection was noted at the puncture site.The vessel was ballooned using a cross over technique and the dissection was solved with adequate restoring of the pulse.At the time of the report the patient was stable.The cause of the dissection was not known, however, a device complication was not suspected.It was not felt that the event was a result of the sheath or the additional force needed to advance the device, as the dissection would likely have been further up the vessel.After device removal, there was no damage noted to the esheath.The patient¿s access vessel was moderately calcified and moderately tortuous.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.Therefore, no visual inspection, functional testing, or dimensional analysis was able to be performed.Patient factors can influence the forces required to insert the delivery system through the sheath.As noted in the training manual, push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.It was noted that the patient¿s anatomy was mildly tortuosity and moderately calcified.Procedural factors can also impact delivery system insertion.It was noted that the loader was fully inserted and locked into the sheath.However, other procedural factors such as improper flushing/wetting of the devices and incorrect de-airing (residual fluid or over inflation of balloon increasing balloon profile) can result in resistance during insertion.Although a definite root cause could not be determined, available information suggests that patient and/or procedural factors may have contributed to the reported events.During manufacturing, the sheath shaft components were 100% visually inspected under minimum 3x magnification for the following: kinks, bends or mechanical damage, circumferentially oriented surface defects, protruding or missing material, dents, and cuts, cross linking across the liner (clear), witness lines with exposed liner, general cleanliness, holes or tears in the strain relief, remnant lines, and soft tip id dimension.The tip interface between tubes is inspected and do not accept tubes with interface showing incomplete fusing, over-stretched material, excessive material, bumps, serrated transition, holes or rough surface.The distal tip is inspected for the presence of scoring and proper scoring on the od and id.During product verification (pv) testing samples underwent and passed the following tests: visual inspection was conducted prior to functional testing for physical defects such as seam separation, holes or tears, and expander insertion force testing.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.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 the failure mode is not required at this time.According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.In this case, the patient¿s access vessel calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the femoral artery dissection.The complaint for sheath shaft - resistance with delivery system, bc was unable to be confirmed.Since the device was not returned for evaluation and no photographs of the device or relevant imagery of the procedure were provided for review, it cannot be determined if a manufacturing nonconformance contributed to the reported event.A review of device history record (dhr), lot history, manufacturing mitigations and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint.Review of complaint history revealed that the occurrence rate did not exceed the (b)(6) 2018 control limit for the trend category ¿resistance between devices¿.Since no manufacturing non-conformances were identified in the product evaluation, and no labeling, training, or ifu deficiencies were identified, no preventative or corrective actions are required.

Manufacturer Narrative

Additional information was received.At the suture site, during closure of the cutdown, a low pulse rate was felt and a catheter was inserted to inspect the site.The dissection was then detected and corrected with a trek balloon.The vessel was pre-dilated with the balloon in the kit.The patient¿s access vessel was mildly tortuous, moderately calcified.Surgical cut-down access was performed.There were no abnormalities detected when inspecting the device prior to use, the loader was fully inserted into the sheath, the introducer was fully inserted into the sheath during device preparation.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: 16FR EDWARDS EXPANDABLE SHEATH
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7583335
• MDR Text Key: 110513942
• Report Number: 2015691-2018-02211
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2018
• Device Model Number: 916ES23
• Device Catalogue Number: 916ES23A
• Device Lot Number: 60626257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR