MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS23J

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Material Deformation (2976)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Encephalopathy (1833); Hypoxia (1918); Rupture (2208)

Event Date 05/18/2020

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, by our edwards lifesciences (b)(6) affiliate, during a tavr procedure via right femoral approach, after successful insertion of a 14fr esheath, the commander delivery system was inserted and, resistance was encountered.The system was advanced past a large area of calcium in the abdominal aorta below the renal artery, however the delivery system was able to pass through the esheath.Following valve alignment, the distal part of valve frame was found to be deformed when angle of fluoroscopic view was changed as the system tracked the aortic arch.The delivery system was pulled back, but the delivery system could not be withdrawn into the sheath as the valve tangled on the sheath distal tip.The entire system and sheath were withdrawn as a unit.Resistance was felt in the lower extremity.After withdrawal, a piece of vessel was noted on the deformed valve frame.The ruptured external iliac artery was repaired with vascular prosthesis.The tavr was performed through the prosthesis and a 2nd delivery system and sapien 3 valve were used to complete the procedure.Approximately 10 days after procedure, the patient expired from hypoxic encephalopathy.Despite multiple attempts, the clinical course was not provided.Per report, post procedure review of the procedural cine, confirmed that the valve frame was deformed when the system passed by the large calcification of abdominal aorta.There was large calcification in abdominal aorta below renal artery.The patient¿s access vessel minimum luminal diameter (mld) measured 5.6 x 7.5 mm at iliac artery, the vascular diameter was 4.5 x 17.8 mm at terminal aorta, and 15.6 mm at level of renal artery.The access vessel was mildly calcified and tortuous.

Manufacturer Narrative

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

Manufacturer Narrative

This supplemental mdr is being submitted for additional information received and correction of the engineering evaluation.The following sections of this report have been updated: b5 (describe event or problem) and h10 (narrative text).Additional 3mensio was reviewed and revealed the location of the protruding calcium.In addition, valve frame was deformed when the system passed by large calcification of the abdominal aorta.The complaint was confirmed based on applicable imagery.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, complaint history review, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As mentioned in the description ¿the procedural cine video showed that the valve frame was stuck with the protruding calcium right after exiting from sheath and the calcium was struck up by the valve frame.¿ it is possible that the interaction between the valve frame and protruding calcification in the abdominal aorta led to tracking difficulty, this interaction most likely led to the valve frame being deformed.As such, per the case description, ¿the delivery system was pulled back, but the delivery system could not be drawn into the sheath as the valve tangled on the sheath distal tip¿ it is possible that the altered profile of the valve may have led to the difficulty experienced when retrieving the valve through the sheath.Per the 3mensio imagery provided, the patient vessels also show calcification, tortuosity and the mld under the minimum requirement of 5.5mm in the terminal aorta.These combined factors may have further exacerbated the withdrawal difficulty.In this case, available information still suggests that patient factors (calcification/tortuosity/undersized mld) and/or procedural factors (bent valve strut) likely contributed to the reported event.No manufacturing non-conformances were identified.Review of complaint history revealed that the occurrence rate does not exceed the may 2020 control limit for the applicable trend category.No ifu/labeling/training manual inadequacies were identified.Therefore, a product risk assessment (pra) not corrective or preventative action is required at this time.

Event Description

Additional information was received: the procedural cine showed that the valve frame was stuck with the protruding calcium right after exiting from sheath and the calcium was stuck up by the valve frame.From what the physician had seen in the cine, delivery system passed through the sheath smoothly.

Manufacturer Narrative

Supplemental mdr is being submitted with reference of mfg.Report numbers.This report is 3 of 3 being submitted for this complaint.Reference mfg.Report numbers: 2015691-2020-12181 and 2015691-2020-12375.

Manufacturer Narrative

The delivery system was returned to edwards for evaluation.Visual inspection revealed the following: the valve was over the inflation balloon at alignment position, stressed area on flex shaft from flex tip, stress mark on flex shaft from flex tip, gouges on flex tip and bent strut on valve.Cine imaging during valve alignment was reviewed and revealed presence of bent valve strut, and delivery system through the sheath with valve over the inflation balloon.The 3mensio imaging was reviewed and revealed access vessel calcification, tortuosity and minimum luminal diameter (mld) under minimum requirements of 5.5 mm in terminal aorta.Dimensional and functional testing was not performed due to the nature of the complaint.During manufacturing visual inspections and tests are performed throughout the process.Per procedure, the balloons are 100% inspected dimensionally and visually.The flex tip outer diameter is 100% dimensionally inspected and verified.During flex catheter preparation the flex shaft is visually inspected for defects.The formed balloons are 100% inspected for fold pattern.During final inspection, per procedure, the guidewire shaft, crimp balloon to balloon shaft bond, flex shaft bond and flex shaft are inspected for defects.In addition, product verification (pv) testing is performed on a lot sampling basis.No failures occurred during product verification testing and the lot was released.The multiple inspections during the manufacturing process support that it is unlikely that a nonconformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing related issues that would have contributed to the reported event.A lot history review was performed and no other complaints for the reported event were noted.A review of the complaint history from june 2019 to may 2020 revealed other similar returned complaints.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggested that patient/procedural factors contributed to the event.A review of complaint history revealed that the occurrence rate did not exceed the may 2020 control limit for all the trend categories.The ifu, device preparation training manual, and procedural training manual were reviewed for instructions or guidance for proper preparation and use of the devices.The ifu provides contraindications and prohibitions for candidate patients.Do not use this device in patients who have the following (access vessel injury may occur): tortuous or calcified vessels that would prevent safe entry of the introducers and expandable sheath.In addition, and edwards expandable sheath (hereinafter, expandable sheath) that provides access into the target vessel while maintaining hemostasis and temporarily enlarges its diameter to allow for passage of the device.Do not use the thv in patients with femoro-iliac vessels diameters 5.5m for 20/23/26mm systems, 6.0mm for the 29mm system.The procedural training manual provides guidance on tracking over the aortic arch.Ensure the edwards logo is facing upon the delivery system, us 30-degree to 40-degree lao to provide view of the aortic arch and slowly rotate the flex wheel away from you while tracking over the aortic arch.No ifu or training deficiencies were identified.The complaint was confirmed based on applicable imagery.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, complaint history review, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As report, ¿the delivery system was pulled back, but the delivery system could not be drawn into the sheath as the valve tangled on the sheath distal tip.¿ provided cine image, revealing that the valve frame deformed.This altered profile of the valve may have led to the difficulty experienced when retrieving the valve through the sheath.In addition, per the 3mensio imagery provided, the patient vessels show calcification, tortuosity and the mld under the minimum requirement of 5.5mm in the terminal aorta.These combined factors may have further exacerbated the withdrawal difficulty.In this case, available information suggests that patient factors (calcification / tortuosity / undersized mld) and / or procedural factors (bent valve strut) likely contributed to the reported event.No manufacturing non-conformances were identified.Review of complaint history revealed that the occurrence rate does not exceed the may 2020 control limit for the applicable trend category.No ifu / labeling / training manual inadequacies were identified.Therefore, a product risk assessment (pra) not corrective or preventative action is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 23MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10149200
• MDR Text Key: 194984240
• Report Number: 2015691-2020-12152
• 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: foreign
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: 9600LDS23J
• Device Lot Number: 62929617
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 83 YR