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

Model Number	1011493-12
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2024168-2022-12253
• Device Sequence Number: 6450155
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 84 KG