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

Catalog Number 1011499-18

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 01/22/2015

Event Type  Injury  

Event Description

It was reported that the herculink elite stent was implanted in the celiac artery and migrated to the femoral artery 1 or 2 days after the stent procedure.The herculink elite was implanted to treat the patient's abdominal pain on (b)(6) 2015.The patient thinks the stent may have migrated on (b)(6) 2015 when she felt a lot of pain.Ct scan was performed on (b)(6) 2015 and showed that the stent was now in the femoral artery.The physician reported that there is blood flowing through the femoral artery.The abdominal pain is less since the stent implant, but the pain is still there.The implanting physician advised the patient and spouse prior to the procedure that the stent may not remain in the same place and may not resolve the patient condition.The patient's anticoagulant was discontinued due to the abdominal pain prior to the stent procedure.The patient's spouse indicated dissatisfaction with the paper stent implant card as it can be damaged if it gets wet.No additional information was provided.

Manufacturer Narrative

(b)(4).Device coding: the herculink elite is labeled for use in the renal artery, but this stent was used in the celiac artery.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances from this lot.A query of the electronic complaint handling database revealed no other incidents reported from this lot.It should be noted that the herculink elite instructions for use states: the rx herculink elite renal stent system is indicated for use in patients with atherosclerotic disease of the renal arteries.Based on the information reviewed, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4554374
• MDR Text Key: 5521007
• Report Number: 2024168-2015-01058
• 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: Consumer
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 1011499-18
• Device Lot Number: 4042461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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): Other
• Patient Age: 70 YR
• Patient Weight: 54