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

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Attachment literature titled: endovascular removal of a balloon expandable superior mesenteric artery stent.Date of event has been estimated.No udi is being reported since the part and lot numbers were not reported.Date of implant has been estimated.Date of explant has been estimated.(b)(4).The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr) was not performed since the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effect of hypersensitivity and pain are listed in the electronic instructions for use rx herculink elite renal and biliary stent system as known patient effects of coronary stenting procedures.It should be noted that the rx herculink elite renal and biliary stent system instructions (ifu) state: 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 (ptra) of a de novo or restenotic atherosclerotic lesion.In this case, the ifu violation did not contribute to the reported complaint.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This event was captured based on literature review of an article titled, "endovascular removal of a balloon expandable superior mesenteric artery stent".It was reported that the index procedure in 2017 was to treat the superior mesenteric artery (sma).A herculink elite stent was implanted and on an unspecified date post implantation, the patient developed abdominal pain and a full rash.This prompted allergy testing which demonstrated cobalt and chromium reactivity.The patient then underwent an endovascular procedure for removal of the herculink elite stent using disposable biopsy forceps with balloon control to prevent distal embolization and a snare to secure the stent to the wire.The patient was discharged on clopidogrel and rivaroxaban on post-procedure day 2 with minimal abdominal pain and improved rash.Details are listed in the attached article.

• Brand Name: RX HERCULINK ELITE BILIARY STENT SYSTEM
• Type of Device: RENAL 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: 7936523
• MDR Text Key: 122796476
• Report Number: 2024168-2018-07692
• 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: literature
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR