MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES, SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During preparation of a 23mm sapien valve, debris on the inside of the valve was noted during rinsing of the valve.An attempt to remove it was unsuccessful.It appeared that the debris was from a blue towel but could not remove it after multiple flushes of saline.Additionally, the doctor tried to remove the debris with forceps.A new valve was requested to be used for the procedure.The valve is being returned.

Manufacturer Narrative

The valve was returned to edwards lifesciences for evaluation.Visual inspection of the returned valve confirmed the presence of a blue fiber on the valve.The blue fiber was visible on all three cusps, however it was longest on cp2, crossing the length of the cusp.On cp1, the blue fiber was in a pinpoint-sized ball with the end unraveled slightly.The image did not capture the blue fiber well, though it was visible during evaluation.The blue fiber on cp3 was not a connected single piece as was observed on cp2.The returned valve was also inspected for any assembly abnormalities, however, no damage or irregularities were observed.Fourier transform infrared (ftir) spectroscopy material analysis was performed.The results indicated that one sample showed similar material absorption characteristics to polyester/cellulose and the second sample was cellophane.The third sample was unable to be determined due to size of particle.During manufacturing, the following processes are in place to mitigate against the potential of particulates or fibers on the sapien 3 valves: 1.The valves were manufactured under controlled environments in cleanrooms.All personnel working or entering edwards' manufacturing facilities must follow specific rules and gowning procedures to reduce particles and control contamination that could impact product.2.During valve assembly, in process glut were changed out daily and at the end of an assembly step once it is completed for the work order and also to enforce use of clean room tape to wipe the removed/cut sutures at the work stations.3.The valves were 100% visually inspected under 8x magnification before and after attachment to the holder.These 100% visual inspections are able to identify presence of any fibers and particles, e.G.Particulates, free sutures, debris, on valves or inside jars.Similarly, in process glut is changed out after the visual inspection is completed for the work order to rinse off any potential loose particulates/sutures in the jar or valves.4.Prior to final packaging, 100% visual inspection was performed at preliminary packaging to ensure no foreign materials (e.G.Particulates, free sutures, debris) are on the valves and inside the jars, visible to unaided eye.A device history record (dhr) review performed revealed no issues that would have contributed to the complaint events.A lot history review did not reveal any other complaints related to ¿valve ¿ particulate, contamination¿ for the work order.Review of complaint history from june 2017 to may 2018 revealed one other returned complaint for particulate contamination that could potentially be related due to the identified blue particle with similar properties.The edwards sapien 3 kit ¿ transfemoral instructions for use (instructions for use) and device prepping manual for sapien 3 valve with commander delivery system were reviewed.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.The complaint for valve ¿ particulate, contamination¿ was confirmed based on visual inspection of returned device.The spectroscopy results confirmed the blue fiber as cellulose/polyester and cellophane.A manufacturing process was performed and no exact match was found based on the physical characteristics of the blue fiber.As reported, the returned device was detailed as having similar properties to the blue towel used in the operating room.Due to no exact matches from the manufacturing process, the blue sterile towel could potentially be the source of the blue fiber found on all three cusps of the valve.Perhaps during handling, lint from the blue sterile towel may have distributed to the valve preparation area and became attached to the fibers of the rough side of the cusps.However, a definitive root cause could not be determined at this time.The complaint was confirmed for the returned device; however, no manufacturing non-conformities were found in the returned sample.No labeling or ifu inadequacies were identified.Review of the dhr and lot history did not reveal any non-conformances for related issues of particulate contamination.Additionally, review of the complaint history revealed that the occurrence rate does not exceed control limits for may 2018; therefore, no corrective or preventative action is required.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS LIFESCIENCES, SAPIEN 3 TRANSCATHETER HEART VALVE, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7538162
• MDR Text Key: 109054896
• Report Number: 2015691-2018-01961
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1