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 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by alterra clinical trials, approximately 5 year post implant of a 29mm sapien valve, ct core lab readings show a stent fracture present and stent penetration/protrusion into the surrounding right ventricle and pulmonary tissue (10 penetrating apices) with the deepest penetration at 5.0 mm.There was no report of any intervention.

Manufacturer Narrative

Correction to section h6.The device was not returned to edwards lifesciences for evaluation.A review of imagery provided showed the following: upon review of the 5 year chest fluoro, three fractures were observed at the alterra inflow (proximal) apices.Additionally, one stent apex was observed penetrating at the inflow and five stent apices at the outflow.One outflow apex was in contact with laa wall.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed additional similar complaints relating to alterra strut fracture.The complaint was confirmed.No manufacturing non-conformances were identified during the evaluation.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.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 complaint was confirmed through the provided imagery.A review of the dhr, lot history, and manufacturing mitigations revealed no indication that a manufacturing non-conformance contributed to the complaint.Additionally, a review of ifu materials revealed no deficiencies.An in-depth evaluation related to alterra prestent fracture and alterra prestent penetration has been documented in technical summary (ts) written by edwards lifesciences.Per 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.Per ts, the alterra prestent is designed with outward flared / pointed apices and sufficient outward chronic force to allow proper retention of prestent to various and challenging patient anatomies.Penetration is a mechanism for anchoring prestent to anatomy and to prevent prestent migration.Four potential root causes related to device penetrations were investigated and summarized below: manufacturing - frames are inspected 100% for critical dimensions per doc-0013850 as well as 100% visually inspected for surface defects in ew receiving inspection and go through lot release radial force testing.However, no manufacturing non-conformances that could have contributed to a penetration were detected as all prestent dimensions and chronic outward force lot release inspections met in process specifications.Design of prestent - alterra prestent is designed with outward flared / pointed apices and sufficient outward chronic force to allow proper retention of prestent to various and challenging patient anatomies.Penetration is a mechanism for anchoring prestent to anatomy and to prevent other risks (e.G.Prestent migration).Patient anatomy - none of the patient features evaluated (e.G.Pulmonary diameters, length, previous cardiac surgeries) could be correlated to an increased risk of a penetration.However, a category 2 penetration is potentially dependent on the proximity of the pulmonary artery with adjacent vasculature.In this case, a category 2 penetration was observed at the outflow apices.Relation to tracking difficulties - a retrospective review of alterra complaints was performed to identify similar occurrences of a delivery system component, commander ds, alterra ds, or pds, catching on the prestent during advancement to deploy the 29mm s3 valve or during withdrawal of the delivery system.However, it cannot be concluded that there is a correlation between interactions of the delivery system with the prestent to the category of penetration.Technical summary documented a review of available ct scans / imagery for patients with a fractured stent.As seen in the provided imagery, three fractures were observed at the alterra inflow (proximal) apices.Per the technical summary, patients who had a fracture exhibited rvot length on the shorter side compared to the population.The technical summary's imagery review also suggested that the fractures were likely to occur where the stent apices were engaged with the bend of the patient's anatomy.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 existed 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.The technical summary reviewed the manufacturing documentation and conducted a sem (scanning electron microscope) micro crack study to determine if 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.The investigation documented in the ts did not reveal any manufacturing non-conformities or procedural related events which could have resulted in the reported complaints.The design of the prestent with outward flared/pointed apices as well as chronic outward force can be identified as potential root causes to the occurrence of penetrations in patients.While a definitive root cause is unable to be determined, available information suggests that patient factors may have contributed to the reported event.Additionally, a product risk assessment (pra) was initiated to assess the risks associated with the frame penetrations.As seen in the provided imagery, one stent apex was observed penetrating at the inflow (proximal) and five stent apices at the outflow (proximal) apices.Per the training manual, the alterra apices are designed to engage with anatomy to assist in initial placement and acute stability.Apex engagement with the anatomy is critical for prestent fixation and to avoid migration.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation 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: 13780360
• MDR Text Key: 290564287
• Report Number: 2015691-2022-04451
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103197266
• UDI-Public: (01)00690103197266(17)180226(10)61013920
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2018
• Device Model Number: 29AP4045CLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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