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

Catalog Number 1011499-15

Device Problems Off-Label Use (1494); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

It was reported that the procedure was performed to treat a 100% stenosed and heavily tortuous lesion in the proximal celiac artery.The 6.0x15mm herculink elite stent delivery system (sds) was advanced with anatomical resistance, and the stent dislodged from the balloon.The sds was removed from the patient anatomy, and the dislodged stent was then retrieved using an unspecified coronary balloon.A 6.0x12mm herculink elite stent was used to successfully complete the procedure.There was no adverse patient sequela.The procedure reportedly took extra time due to the stent dislodgement; however, the delay was not clinically significant.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: analysis was performed on the returned device.The reported stent dislodgment was confirmed.The reported physical resistance could not be replicated in a testing environment as the stent delivery system was not returned and it was based on procedural circumstance.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 incidents from this lot.It should be noted that the rx herculink elite renal and biliary stent system instructions for use 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 is unknown if the use anatomical location contributed to the reported event.The reported physical resistance advancing the device and stent dislodgment appear to be related to interaction with the patient anatomical conditions.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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
• MDR Report Key: 8242006
• MDR Text Key: 132904001
• Report Number: 2024168-2019-00309
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 1011499-15
• Device Lot Number: 8031361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 49