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

Model Number	1011487-15
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
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 the procedure was to treat a 90% stenosed, heavily tortuous de novo lesion in the left vertebral artery.The 4.0x15 mm rx herculink elite stent delivery system (sds) failed to cross due to the anatomy.The sds was removed without any issues.Once outside the patient anatomy the stent dislodged.Another 4.0x15mm rx herculink elite sds was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported failure to advance was not tested as it was based on case circumstances.The stent dislodgment was confirmed.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 complaints.The investigation determined that the reported failure to advance and stent dislodgment were due to case circumstances.It is likely that anatomical conditions contributed to the reported failure to cross.It is likely that the stent became compromised (loosened) on the balloon during the failed attempt to advance resulting in dislodgment of the stent once removed from the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10876826
• Report Number: 2024168-2020-09781
• Device Sequence Number: 11525305
• Product Code: NIN
• UDI-Device Identifier: 08717648077838
• UDI-Public: 08717648077838
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 07/31/2023
• Device Model Number: 1011487-15
• Device Catalogue Number: 1011487-15
• Device Lot Number: 0080761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1