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

Model Number 1011493-12

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the proximal right iliac artery with 95% stenosis, presence of calcification and heavy tortuosity.The 5.0x12mm herculink stent delivery system (sds) had resistance during advancement due to the anatomy and force was applied to traverse the tortuosity and the lesion resulting in the stent coming off the balloon.A snare device was used in an attempt to remove the stent but was unsuccessful.An omnilink stent was deployed to crush the herculink stent in the left iliac artery.Another omnilink stent was used to complete the procedure.There was no adverse patient effect.There was report of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for evaluation.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.It was reported that the 5.0x12mm herculink stent delivery system (sds) had resistance during advancement due to the anatomy and force was applied.It should be noted that the rx herculink elite peripheral stent system instructions for use (ifu) states: should unusual resistance be felt at any time during stent advancement, deployment, or retraction of the stent, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.If possible, retain the guide wire position for subsequent vessel access.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and stent delivery system components, or damage to the vessel.It is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported difficulties and subsequent treatment, including device embedded in tissue or plaque and delay to treatment/therapy, appears 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: 15924701
• MDR Text Key: 304900185
• Report Number: 2024168-2022-12253
• Device Sequence Number: 1
• Product Code: NIN
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1011493-12
• Device Catalogue Number: 1011493-12
• Device Lot Number: 0091061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG