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

Model Number	1011487-12
Medical Device Problem Codes	Failure to Advance (2524); Malposition of Device (2616); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the procedure was to treat a heavily calcified, mildly tortuous de novo right renal artery that is 70% stenosed.The 4.0x12mm herculink elite balloon-expandable stent system (bess) failed to cross the lesion due to anatomy.The bess was deployed in the anatomy at an unintended site due to flared stent struts as the physician thought the stent might dislodge if the device kept attempting to be advanced.Another unspecified device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned product.The reported failure to advance, stent damage and malposition of device was not tested as it was based on procedural circumstances and the stent was not returned.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 revealed no other complaints reported from this lot.The investigation determined that the reported difficulties were due to case circumstances.It is likely that anatomical conditions contributed to the reported failure to cross and stent damage.It is likely that the stent became compromised on the balloon (flared struts) during the failed attempt to advance resulting in the decision of the physician to deploy the stent in an unintended location to prevent dislodgement.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 12360393
• Report Number: 2024168-2021-07458
• Device Sequence Number: 3874020
• Product Code: NIN
• UDI-Device Identifier: 08717648077821
• UDI-Public: 08717648077821
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 07/31/2023
• Device Model Number: 1011487-12
• Device Catalogue Number: 1011487-12
• Device Lot Number: 0081061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 10/02/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other