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

Model Number 29AP4045CLUS

Device Problem Fracture (1260)

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

Event Date 03/04/2022

Event Type  malfunction  

Event Description

As reported through clinical trial, a single wire frame fracture of the one of the inflow portions of the alterra device was found via fluoroscopy at subject's 4-year visit.No loss of structural integrity and no clinical manifestations noted.

Manufacturer Narrative

Investigation is ongoing.Remains implanted.

Manufacturer Narrative

Update to b4, g3, g6, h2, h6 and h10 to reflect no device return evaluation.No product was returned, therefore no visual inspection, functional testing or dimensional testing could be performed.The complaint event site provided imagery relevant to the complaint.Upon review of the 4 year chest x-ray, two fractures were observed at the alterra inflow (proximal) apices.The review of the related work orders did not reveal any manufacturing non-conformance issues that would have contributed to the event.A lot history review was performed using both the lot number of the fully assembled alterra system (frame & delivery system), and all of the frame serial numbers listed within the related work order.During receiving inspection, the alterra frame components underwent multiple inspections.Additionally, product verification (pv) testing was performed on each lot under a sampling plan prior to product release.All samples passed this pv test.These manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.The ifu for edwards alterra adaptive prestent system ifu and procedural training manual were reviewed for guidance and instruction on device preparation and usage involving alterra prestent delivery system usage.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.The strut fracture 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 has been documented in a technical summary written by edwards lifesciences, 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 documented a review of available ct scans / imagery for patients with a fractured stent.As seen in the provided imagery, upon review of the 4 year chest x-ray, two fractures were found the alterra prestent 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.Additionally, the technical summary reviewed the manufacturing documentation and conducted a 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.While a definitive root cause is unable to be determined, available information suggests that patient factors may have contributed to the reported event.Since no product non-conformance or ifu deficiencies were identified during evaluation, and the occurrence rates did not exceed the trigger for additional review, a product risk assessment is not required.However, per management's discretion, a product risk assessment has been initiated to assess the risks associated with the failure mode.Since no edwards defects were identified, no corrective/preventative actions are required.

• Brand Name: ALTERRA ADAPTIVE PRESTENT
• 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: 14002744
• MDR Text Key: 288614684
• Report Number: 2015691-2022-04823
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103197266
• UDI-Public: (01)00690103197266(17)180326(10)61305410
• 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: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2018
• Device Model Number: 29AP4045CLUS
• Device Lot Number: 61305410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2018
• 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