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

Model Number	1011499-15
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during unpacking of a 6x15mm herculink stent, it was noted that the stent implant was loose on the balloon (still remaining on the delivery system).There were no issues noted with the chipboard box or dispenser hoop coil.The device was not used and there was no patient involvement.Another same sized device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.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.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 of the device.B6: relevant test/laboratory data updated b7: other relevant history updated h6: health effect impact code 2645 was removed.
Event or Problem Description
It was reported that during unpacking of a 6x15mm herculink stent, it was noted that the stent implant was loose on the balloon (still remaining on the delivery system).There were no issues noted with the chipboard box or dispenser hoop coil.The device was not used and there was no patient involvement.Another same sized device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, the account confirmed that the procedure was to treat a renal artery that was 80% stenosed and was used in the patient anatomy; there was patient involvement unlike what was initially reported.The device failed to cross due to anatomy and via angiography it was noted that the stent implant was loose on the balloon (still remaining on the delivery system).Another stent was used to successfully complete the procedure.No additional information was provided.

• 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: 12546889
• Report Number: 2024168-2021-08727
• Device Sequence Number: 1113925
• Product Code: NIN
• UDI-Device Identifier: 08717648078194
• UDI-Public: 08717648078194
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1011499-15
• Device Catalogue Number: 1011499-15
• Device Lot Number: 0071661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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
• Patient Sex: Unknown