MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number UNK SUPERA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Vasoconstriction (2126); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 03/01/2020

Event Type  Injury  

Event Description

It was reported in a research article that sixty patients were treated with a supera stent in the juxta-anastomotic stenosis (jxas) in the radiocephalic arteriovenous fistula (avf) which were failing, particularly where previous interventions have failed.The aim of the study was to determine the long term patency and clinical outcomes for hemodialysis patients after the implantation of the supera to treat the jxas.The area was pre-dilated with an armada balloon and the supera stent was then deployed.Two procedures encountered difficulty in retrieving the delivery system of the supera as the tip caught on the stent.Manipulation of the guide wire allowed for the tip to detach and the delivery system was then removed.An additional 19 patients also had an absolute pro stent implanted in the more proximal cephalic vein.Spasm of the radial artery was observed during the procedure, which was allowed to resolve without intervention.Bruising was observed in 10 cases and was resolved by the first clinical follow up.Malapposition of the supera stent was noted but this was associated with statistcally significant improved stent patency, while post dilatation of the stent is associated with earlier statistically significant restenosis.There was stent restenosis as well as thrombosis of the avf which was managed with angioplasty/thrombectomy.Additional details can be found in the attached article titled, 'long-term results of interwoven nitinol stents to treat the radiocephalic anastomotic arteriovenous fistula stenosis'.

Manufacturer Narrative

B3: the date of event is estimated.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.Reportedly, sixty patients were treated with a supera stent in the juxta-anastomotic stenosis (jxas) in the radiocephalic arteriovenous fistula (avf).It should be noted that the supera peripheral stent system instructions for use (ifu) states: the supera peripheral stent system is indicated for peripheral vascular use following percutaneous transluminal angioplasty (pta) and palliative treatment of biliary strictures produced by malignant neoplasms.The reported patient effects of stenosis, thrombosis, hematoma and vessel spasm/recoil (vasoconstriction) are listed in the supera peripheral stent system instructions for use (ifu) as potential adverse effects of peripheral percutaneous intervention.A conclusive cause for the reported stenosis, thrombosis, hematoma and vasoconstriction, and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The malfunctions reported in the article are captured under a separate medwatch report number.Attachment: article titled, 'long-term results of interwoven nitinol stents to treat the radiocephalic anastomotic arteriovenous fistula stenosis'.

Manufacturer Narrative

H6: medical device problem code 1494 / incorrect anatomyh6: added: 'medical device problem code 1494 / incorrect anatomy'.

Event Description

It was reported in a research article that sixty patients were treated with a supera stent in the juxta-anastomotic stenosis (jxas) in the radiocephalic arteriovenous fistula (avf) which were failing, particularly where previous interventions have failed.The aim of the study was to determine the long term patency and clinical outcomes for hemodialysis patients after the implantation of the supera to treat the jxas.The area was pre-dilated with an armada balloon and the supera stent was then deployed.Two procedures encountered difficulty in retrieving the delivery system of the supera as the tip caught on the stent.Manipulation of the guide wire allowed for the tip to detach and the delivery system was then removed.An additional 19 patients also had an absolute pro stent implanted in the more proximal cephalic vein.Spasm of the radial artery was observed during the procedure, which was allowed to resolve without intervention.Bruising was observed in 10 cases and was resolved by the first clinical follow up.Mal apposition of the supera stent was noted but this was associated with statistcally significant improved stent patency, while post dilatation of the stent is associated with earlier statistically significant restenosis.There was stent restenosis as well as thrombosis of the avf which was managed with angioplasty/thrombectomy.Additional details can be found in the attached article "long-term results of interwoven nitinol stents to treat the radiocephalic anastomotic arteriovenous fistula stenosis".Subsequent to the initially filed serious injury report, it was reported that the manipulation of the guide wire was performed to move the tip away from the stent and once the tip was moved away, the delivery system was then removed whole.No additional information was provided.

• Brand Name: SUPERA
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18278849
• MDR Text Key: 329888663
• Report Number: 2024168-2023-13549
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male