MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM; RENAL STENT SYSTEM

Catalog Number	1011505-18
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: a visual inspection was performed on the returned device.The dislodged stent was confirmed.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 of the reported lot revealed no other similar incidents.The rx herculink elite instructions for use (ifu) instructs: prior to using the rx herculink elite peripheral stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent is located between the radiopaque balloon markers.Do not use if any defects are noted.The investigation was unable to determine a cause for the reported stent dislodgment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the right renal artery.The 7.0 x 18 mm herculink stent delivery system (sds) was prepped.The device was flushed outside the patient anatomy and advanced over the guide wire.Once inside the guide catheter, negative was pulled.The device was advanced into the anatomy and was able to cross the lesion.The balloon was inflated and it was noted that the stent was not on the balloon.Imaging was performed to locate the dislodged stent, but was not found in the anatomy, on the sds, on the guide wire or in the guiding catheter.The herculink delivery system was removed without issue.A non-abbott stent delivery system was used to successfully complete the procedure.After the procedure, the preparation table and protective sheath were looked at but the stent was not found.The physician is certain that the stent is not in the patient anatomy.Additionally, it was not noted if the stent was present on the delivery system during device preparation or if it was completely missing from the stent delivery system.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: RENAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7992645
• Report Number: 2024168-2018-08089
• Device Sequence Number: 19275949
• Product Code: NIN
• UDI-Device Identifier: 08717648078385
• UDI-Public: 08717648078385
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 02/28/2021
• Device Catalogue Number: 1011505-18
• Device Lot Number: 8030861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 88