MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23J

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in (b)(6), during valve preparation, ¿foreign material¿ was found on the 23mm sapien 3 valve.It was not known if the material had existed in the jar prior to opening or was ¿mixed¿ after opening.After removing the foreign material, the sapien 3 valve was deployed in the patient without injury or complication.The material will be returned to edwards lifesciences for evaluation.The valve remains implanted in the patient.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.The foreign material (reddish-brown particle) was returned to edwards lifesciences for evaluation.The valve remains implanted in the patient and was not returned for evaluation.Visual inspection of the particulate material revealed a solid reddish-brown particulate approximately 0.65mm x 1.1mm.Material analysis was performed on the isolated material collected from the complaint site with fourier transform infrared spectroscopy (ftir).The results scan from ftir indicated the reddish - brown material showed similar absorption characteristics when comparing to ¿tween like material¿.A review of manufacturing process was performed in order to determine if the ¿tween like particulate¿ could have originated at edwards singapore facility.A listing of all the tooling, fixtures and material used in the manufacturing line of 9600tfx valve were generated and.Tween is used during the manufacturing process for the components used during valve assemble.However, given the size of the particulate, it is unlikely that the particulate is a result of the manufacturing process.Therefore, it is not confirmed that the tween like material collected during evaluation originated from the thv manufacturing process for valve assembly at edwards singapore facility.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar complaints.It should be noted that lot numbers for valve complaints reference the valve serial number only.Therefore, the review was performed by taking the valve serial numbers from the appropriate work order and verifying that there has been no other complaint associated with each serial number.Complaint history review from september 2018 through august 2019 revealed other returned complaints for the sapien 3 valve for the appropriate complaint code.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.A review of complaint history reveals that the occurrence rate did not exceed the august 2019 control limits for the appropriate trend category.Per the ifu and training manuals preparation of the thv before mount and crimp onto the delivery system includes table setup, sheath introducer set preparation, balloon catheter reparation, thv rinsing, delivery system preparation and qualcrimp crimping accessory rinsing.Once prep tasks listed above have been all completed, mount and crimp thv on delivery system will be executed per instructions.The 2nd and 3rd steps are ¿take thv and holder out of rinse bowl¿ and ¿remove thv from holder using sterile scissors¿.During thv rinsing, the valve needs to be removed from the jar using forceps and checked for frame, tissue damage, id tag/jar lid sn verification, and rinsed with two separate saline solutions for total of 2 minutes minimum.No ifu/training deficiencies were identified for the procedure that could potentially lead to this complaint.In this case, the complaint was confirmed.The reddish-brown particulate observed during visual evaluation was tested and the results indicated the particulate is a ¿tween like material¿.While tween is used in the manufacturing process, it is only found in liquid form when mixing the raw material used.Additionally, the solution is filtered through a fine micrometer filter before being used.Therefore, it is unlikely that the particulate is originated from edwards.Since the reddish-brown particulate was found during device preparation (out of the jar), it is possible that the particulate was originated from field.Since no defects or labeling/ifu/training deficiencies were identified, no corrective or preventative actions are required at this time.However, an awareness communication emphasizing the importance of in-process mitigation on foreign particulate during manufacturing was performed as a precautionary measure.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8917256
• MDR Text Key: 196083124
• Report Number: 2015691-2019-03103
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2019

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: 05/01/2021
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 01/30/2020; 07/23/2020
• Supplement Dates FDA Received: 02/05/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1