MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ALTERRA ADAPTIVE PRESTENT SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 29AP4045CLUS

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

As reported by alterra clinical trials, approximately 1 year 21 days post a transcatheter pulmonic valve replacement procedure with a 29mm sapien 3 valve in an alterra prestent, a 'type 1 fracture' was observed at the inflow of the alterra prestent.There was no report of an injury to the patient or intervention being required.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional information received.The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done, and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and the reported event for those similar events were confirmed.No manufacturing non-conformances were identified during the evaluation.While a definitive root cause is unable to be determined, available information suggests that patient factors may have contributed to the reported event.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The site provided imagery relevant to the event, and the following was observed: upon review of the 12-month chest x-ray, one new fracture at the alterra inflow (proximal) apices was found.The complaint for strut fracture was confirmed through the provided imagery.The following instructions for use (ifu) and training manuals were reviewed for guidance and instruction on device preparation and usage involving alterra prestent delivery system usage: ifu for edwards alterra adaptive prestent system, and procedural training manual.Based on this review, there were no ifu/training deficiencies were identified.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.An in-depth evaluation related to alterra prestent fracture has been documented in a technical summary written by edwards lifesciences.Per the technical summary, the prestent in straight configurations is safe under pulsatile loads based on the finite element analysis (fea) models, accelerated wear and tear (awt) and fatigue testing.As such, the potential fracture on the proximal end of the frame could be attributed to the conditions of the patient's anatomy.The technical summary also documented a review of available ct scans / imagery for patients with a fractured stent.Per the technical summary, patients who had a fracture exhibited rvot length on the shorter side compared to the population.It also suggested that the fractures were likely to occur where the stent apices were engaged with the bend of the patient's anatomy.As seen in the provided imagery, a strut fracture was observed on the 12 month chest x-ray.The image indicated two fractures on the proximal (inflow) portion of the prestent.It is possible that this positioning resulted in some apices of the inflow side of the stent engaging with anatomy, putting strain on the stent.However, as there were existing patients with similar anatomical conditions that did not have fractures, the technical summary concluded that shorter rvot length, increased curvature, and increased level of engagement do not dictate a fracture but may increase the risk of one.Additionally, review of the manufacturing documentation and an sem (scanning electron microscope) micro crack study to determine whether microcracks could be present on the frame prior to implantation of the pre-stent.No microcracks were observed on the frames at any phase of the investigation and no evidence of a manufacturing non-conformance that could have contributed to the complaint event was found.While a definitive root cause is unable to be determined, available information suggests that patient factors may have contributed to the reported event.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.

• Brand Name: ALTERRA ADAPTIVE PRESTENT SYSTEM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 13283215
• MDR Text Key: 284998578
• Report Number: 2015691-2022-03448
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103197266
• UDI-Public: (01)00690103197266(17)210312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: 29AP4045CLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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