MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS EXPANDABLE INTRODUCER SHEATH SET; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 916ES23A

Device Problems Split (2537); Torn Material (3024); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

During a transvenous pulmonary replacement procedure, a 23mm sapien xt valve was implanted in a pre-existing pulmonary homograft conduit.It was reported that ¿normal¿ resistance was noted while advancing the novaflex+ (nf+) delivery system and valve through the 16fr.Esheath.When the delivery system reached the tip of the sheath, it could not be moved forward.After a few unsuccessful attempts to advance the system, extra force was applied.The sheath tip felt like it ¿popped¿ and the delivery system/valve ¿jumped¿ forward, out of the tip of the sheath.The delivery system was then able to be advanced and aligned in the usual fashion and the sapien xt valve was successfully deployed.Following the deployment of the valve, the nf+ delivery system was removed without issue.Following the removal of the esheath, the tip appeared to be torn, but not along the seam.All sheath material appeared to be present.

Manufacturer Narrative

Additional information: the esheath was returned to edwards for evaluation.Visual inspection revealed the sheath liner was fully expanded with no liner tear.The distal tip was torn along the vertical and horizontal score lines.Distal tip material stretching along the score lines was observed.No damage was observed on the sheath distal tip.No other abnormalities were observed on the returned sheath.Imagery from the case was provided by the site.The case video confirmed the reported ¿pop¿ and ¿jump¿ observed when the delivery system was pushed through the sheath distal tip.No functional testing or dimensional analysis was performed due to the nature of the complaint.Dhr review of the components most relevant to the complaint event was performed.The work orders did not reveal any issues that could have contributed to the reported event.A lot history review was performed.No other complaints for ¿sheath distal tip ¿ torn¿ or ¿sheath shaft ¿ resistance with delivery system¿ were found.A review of the complaint history from february 2017 to january 2018 revealed 9 other returned complaints for the edwards expandable introducer sheath set (all models and sizes) for ¿sheath distal tip ¿ torn¿.Four (4) complaints were confirmed and potential manufacturing defects (tip under-scoring) were identified.Awareness training for this issue was performed.One (1) complaint was confirmed; however, no manufacturing non-conformances were identified.Two (2) complaints were confirmed, but a definite root cause was not able to be determined.Two (2) complaints are pending engineering evaluations.A review of the complaint history revealed that the occurrence rate did not exceed the january 2018 control limits for trend category ¿tip torn¿.A review of the complaint history from february 2017 to january 2018 revealed 21 other returned complaints for the edwards expandable introducer sheath set (all models and sizes) for ¿sheath shaft ¿ resistance with delivery system, bc¿.Five (5) complaints were not able to be confirmed, but no potential manufacturing non-conformances were identified.Twelve (12) complaints were confirmed, but no potential manufacturing non-conformances were identified.One (1) complaint was confirmed.The sheath distal tip was also observed to be torn.A definite root cause was not determined; however, a potential manufacturing non-conformance (tip under-scoring) may have contributed to the event.One (1) complaint was unable to be confirmed, but the sheath distal tip was observed to be separated.A definite root cause was not determined; however, a potential manufacturing non-conformance (tip under-scoring) may have contributed to the event.Two (2) complaints are pending engineering evaluations.A review of the complaint history revealed that the occurrence rate did not exceed the january 2018 control limits for trend category ¿resistance between devices¿.Review of the ifu/training manuals did not identify any deficiencies.During the manufacturing process of the sheath shaft subassembly, the soft tip is visually inspected for incomplete tip bonding, cross linking and circumferential lines on coex.During final inspection, the subassembly is inspected for the soft tip inner diameter (id), tip flash, tears, holes, folds, misalignment, bubbles, strain relief holes, tears, wrinkles and coex gap.The sheath is also inspected for general cleanliness.During final assembly, the sheath undergoes multiple 100% visual inspections for defects and flash.The esheath also undergoes multiple 100% inspections by manufacturing and quality for wrinkles, kinks, bends, mechanical damage, flash and excess material.Following sterilization, product verification (pv) testing is performed on finished devices from each lot under a sampling basis.Following visual inspection and sheath expansion testing, the devices are inspected for damage, liner opening or not, and to ensure no fragments have separated from the sheath tip.The devices from this lot met all requirements for all inspections and tests.These manufacturing inspections support that proper inspections are in place to detect issue related to the reported event.A review of risk documentation revealed that the potential event is anticipated in the risk management file.High push force (resistance) required to advance compatible device through the sheath or loader may result in a procedural delay.Severity level of 2.Improper scoring with a potential of high insertion force.Severity level of 2.Due to previously identified manufacturing non-conformance for this issue, a capa was initiated to investigate the issue.As a result of the investigation, procedures were clarified and operator re-training was performed.In this case, the complaints foo ¿sheath distal tip ¿ torn¿ and ¿sheath shaft ¿ resistance with delivery system, bc¿ were confirmed based on visual inspection.The distal tip was torn along the score path.A review of the dhr, lot history did not reveal any indication that a manufacturing non-conformance contributed to the event.Review of the ifu/training manual revealed no deficiencies.The complaint history review revealed that the radial distal tip tearing was previously investigated as part of a capa.The results of the capa investigation revealed improper scoring at the distal tip was the root cause for the radial tip tearing.The observed distal tip material stretching along the score line indicated there was possible improper scoring.The possible improper scoring may have contributed to the increased insertion force required to exit the sheath distal tip, resulting in the reported ¿pop¿ when the valve existed the sheath.It is possible that a manufacturing non-conformance (insufficient scoring of the distal tip) contributed to the complaint event.No labeling or ifu inadequacies have been identified and review of the complaint history revealed that the occurrence rates do not exceed the january 2018 control limits for the failure modes.The work order was initiated before the awareness training was performed on 10/18/2017; therefore no additional corrective or preventive action is required.

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7261339
• MDR Text Key: 99903087
• Report Number: 2015691-2018-00450
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• 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
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2019
• Device Model Number: 916ES23A
• Device Lot Number: 61088277
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR