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

Model Number	1011487-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat an 80% stenosed and mildly calcified lesion in the right renal artery.A 4.0x12mm herculink elite balloon expandable stent system (bess) was advanced and pressurized to 8 atmospheres; however, the stent failed to deploy.The procedure was successfully completed with an unspecified 4.0x12mm stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspections were performed on the returned stent delivery system (sds).The reported stent deployment issue was unable to be confirmed as the stent was deployed without any issues noted.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 similar incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported activation/deployment issues.In this case, it is possible that the accessory devices used during the procedure where on the off position preventing inflation of the catheter and the stent deployment; however, this could not be confirmed.The noted stent movement and proximal shaft bend likely occurred during packing for return analysis.There were visible crimp marks on the balloon suggesting the stent was originally positioned correctly and securely at the time of manufacture.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 12345599
• Report Number: 2024168-2021-07327
• Device Sequence Number: 19767005
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 09/30/2022
• Device Model Number: 1011487-12
• Device Catalogue Number: 1011487-12
• Device Lot Number: 9100962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1