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

Model Number	1011493-15
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
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.2017-above rbpna.
Event or Problem Description
It was reported that the procedure was performed to treat the moderately calcified, heavily calcified right renal artery that was 50% stenosed.The 5.0x15mm herculink elite stent delivery system was pressurized to 14atm but failed to inflate.The device was then pressurized to 20atm and the stent only partially opened.It was then attempted to pull back the balloon, but resistance was noted.The delivery catheter was removed using the guiding catheter.It was observed via x-ray that the stent was not completely opened.An unspecified balloon catheter was used to fully deploy the stent.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned stent delivery system (sds).The reported inflation problem, stent deployment issue and difficulty to remove were unable to be replicated in a testing environment 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 similar incidents and/or complaints reported from this lot.It should be noted that the rx herculink elite renal and biliary stent system instructions for use (ifu) states: balloon pressures should be monitored during inflation.Do not exceed rated burst pressure (rbp) as indicated on product label.Use of pressures higher than specified on product label may result in a ruptured balloon with possible vessel damage or perforation.In this case, the reported ifu violation of inflation above rated burst pressure does not appear to have caused or contributed the reported complaint.The investigation determined the reported inflation problem, activation/deployment failure and difficulty to remove appear to be related to operational circumstances of the procedure.In this case, it is likely that during stent deployment, the challenging anatomical conditions prevented the stent from fully deploying during inflation of the sds resulting in the incomplete stent deployment and inflation issue.Additionally, it is likely that the anatomy was the cause of the difficulty to remove.The treatment appears to be related to the operational context of the procedure as an unspecified balloon catheter was used to fully deploy the stent.The noted stretched guide wire notch and bends likely occurred during packaging for return analysis.It is unknown what type of wire was returned wrapped around the balloon.No wire issues or contamination issues were reported.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: 12001749
• Report Number: 2024168-2021-04996
• Device Sequence Number: 1099031
• Product Code: NIN
• UDI-Device Identifier: 08717648078019
• UDI-Public: 08717648078019
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 01/31/2024
• Device Model Number: 1011493-15
• Device Catalogue Number: 1011493-15
• Device Lot Number: 1021161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: Required Intervention