MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Catalog Number 1011528-12

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported material deformation and device dislodge or dislocated were confirmed.The reported failure to advance could not be tested as it was based on operational context.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 identified no other incidents from this lot.The investigation determined the reported failure to advance and material deformation appear to be related to the operational context of the procedure.However; a conclusive cause for the reported device dislodge or dislocated could not be determined.In this case it is likely that the stent delivery system (sds) interacted with the patient¿s anatomy during advancement, as resistance was noted, resulting in the reported failure to advance and subsequent material deformation (flared struts).Factors that may contribute to a dislodged stent include, but are not limited to, improper or inadequate crimping at the time of manufacture, forced sheath removal, mishandling of the stent, interaction with challenging anatomy, and/or interaction with accessory devices.In this case, it is possible that inadvertent mishandling of the stent after it was removed from the anatomy may have contributed to the reported stent dislodgement.However; this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the renal artery.The stent system was advanced, but failed to reach the lesion.The struts became damaged and the stent became misaligned on the delivery system, but remained on the delivery system throughout the procedure.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15237920
• MDR Text Key: 298579562
• Report Number: 2024168-2022-08815
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011528-12
• Device Lot Number: 1081161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1