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

Catalog Number 1011492-15

Device Problems Unintended System Motion (1430); Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the lot number was not reported.It should be noted that the rx herculink elite renal and biliary stent system instructions for use (ifu) states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty of a de novo or restenotic atherosclerotic lesion located within 10 mm of the renal ostium.In this case, it could not be determined if the off-label use caused or contributed to the reported difficulty.It may be possible that the balloon was inflated too quickly resulting in uneven stent expansion or stent slippage relative to balloon; however, this could not be confirmed.The additional therapy/non-surgical treatment was due to case related circumstances.The investigation was unable to determine a cause for the reported difficulty.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a tortuous lesion in the vertebral artery.A 5.0 x 15 mm herculink stent delivery system (sds) was advanced to the lesion with no resistance.On attempting to deploy the stent, the balloon of the sds appeared to move/ slip and the stent was ultimately deployed partially at the target lesion and partially into the subclavian artery.Balloon angioplasty was required to dilate the end of the stent that deployed in the subclavian artery to improve the wall apposition with satisfactory results.Patient was reported to be doing well post procedure and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8688125
• MDR Text Key: 147632290
• Report Number: 2024168-2019-04591
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/11/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 1011492-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention