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

Model Number 1011493-12

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the renal artery that is 80% stenosed.The 5.0x12mm herculink elite stent delivery system (sds) was advanced to the target lesion.Resistance was noted during advancement; however, it is unknown what the device met resistance with.The stent was observed to have moved on the balloon in the sheath and failed to cross the lesion.The sds was removed with the stent still on the sds and a new 5.0x12mm herculink elite was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance and difficult to advance/position could not be evaluated as the exact accessory devices and anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.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 similar incidents from this lot.A conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

Subsequently, after the initial was filed it was noted that an attempt was made to inflate the balloon to secure the stent after it was observed moved; however the stent was in the sheath.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: 16506432
• MDR Text Key: 310992254
• Report Number: 2024168-2023-02401
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078002
• UDI-Public: 08717648078002
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• 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: 2021861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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