MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM

Catalog Number 1011533-18

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional herculink elite device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was performed to treat a heavily calcified lesion in the mid renal artery.A 7.0x18mm and 6.0x18mm rx herculink elite stent systems were prepared per the instructions for use.One stent system was advanced; however, resistance with the anatomy was felt.An attempt to remove the stent system was made, but resistance with the 5f sheath was felt and excessive force was required to remove the stent system.After removal, it was noted that the stent strut was flared.The second stent system experienced the same issues.Two new same size herculink stents were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual and dimensional inspection was performed on the returned device.The stent damage was confirmed.The failure to advance difficulty removing could not be confirmed due to the damaged stent.The rx herculink elite instruction for use warns: should unusual resistance be felt at any time during either lesion or duct access, or during removal of an undeployed stent, the stent system, wire, and guiding catheter should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.The excessive force does not appear to have caused the reported difficulties.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The failure to advance was due to anatomy which was described as heavily calcified.Additionally, it is likely that after the failed attempt to advance, the stent became damaged on the balloon.The resistance during removal was likely due to interaction between the introducer sheath and the flared stent struts.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8729139
• MDR Text Key: 149070048
• Report Number: 2024168-2019-05026
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• 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
• Report Date: 07/25/2019

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: 10/31/2021
• Device Catalogue Number: 1011533-18
• Device Lot Number: 8111261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 5 FRENCH ARROWFLEX