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

Model Number 1011493-12

Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

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

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat a lesion in the 100% occluded ostial superior mesenteric artery (sma).The herculink elite stent delivery system was advanced over a long spartacore guide wire.No issues were noted during advancement with the guide wire, but difficulty was noted advancing the herculink elite due to the patient anatomy, so removal of the device was initiated; however, during removal, resistance was noted with the guide wire.The device was pulled and the herculink elite stent delivery separated at a location outside the patient anatomy.After removing the proximal device, the proximal guide wire was cut to remove the herculink elite separated segment.The procedure continued using the same cut guide wire.A second herculink elite was then implanted without issue.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The spartacore guide wire mentioned is filed under a separate medwatch mfr report number.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported material separation and difficult to remove from the guide wire was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.Additionally, the balloon was noted to be bunched and wrinkled and the inner member was noted to be bunched and stretched.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely the device interacted with the 100% stenosed lesion during advancement causing the reported failure to advance, noted bunched balloon, and bunched inner member.A buildup of procedural contaminants likely contributed to the reported difficult to remove (guide wire resistance), causing the noted wrinkled balloon.Further interaction with the procedural contaminates while attempting to retract the device over the guide wire likely contributed to the reported difficult to remove and noted stretched inner member, ultimately causing the reported material separation (shaft) and noted separation of the proximal seal.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 13609361
• MDR Text Key: 287586078
• Report Number: 2024168-2022-02041
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011493-12
• Device Catalogue Number: 1011493-12
• Device Lot Number: 1052061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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
• Treatment: HI-TORQUE SPARTACORE GUIDE WIRE.
• Patient Age: 81 YR
• Patient Sex: Female