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 Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 01/06/2016

Event Type  Injury  

Event Description

It was reported through a research article that 28 patients were had an endovascular repair of the popliteal artery aneurysms (paas) with a supera stent.Twenty-three patients paas were asymptomatic and 6 presented with symptoms.It was noted in all cases a.018 steelcore guide wire was used for insertion and deployment of the stent with no issue and the preclose porgilde was used in two cases with no issue.During the 28 cases there were no issues during the procedure; however, once one case did require surgical correction 5 days later of the pseudoaneurysm that developed at a common femoral artery at the site of percutaneous access.It was noted the complication occurred after manual compression; therefore, prolonging the hospital stay.Other complications that arose after the 6 month follow up was in two cases aneurysm thrombosis occurred, while at the 12 month follow up a total of 10 patients.The diameter of the aneurysm remained stable in all other cases, with a 100% freedom from sac enlargement.One death was noted; however, it was revealed the death was not related to the aneurysm or the procedure it was due to ovarian cancer.For endovascular repair of paas, the use of a thick interwoven-wire stent showed encouraging mid-term results with no cases of stent fractures, occlusion or aneurysm increase.Specific patient information is documented as unknown.Details are listed in the attached article, titled "outcome of endovascular repair of popliteal artery aneurysms using the supera stent." no additional information was provided.

Manufacturer Narrative

B3, b6, d6a: dates estimated.D4: the udi is unknown due to the part/lot number was not provided.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number was not provided.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.The reported patient effects of thrombosis and pseudoaneurysm are listed in the supera peripherial stent system instructions for use as potential adverse effects of peripheral percutaneous intervention.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature attachment: article title: outcome of endovascular repair of popliteal artery aneurysms using the supera stent.

• 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: 18187258
• MDR Text Key: 328736489
• Report Number: 2024168-2023-12977
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/21/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2023
• 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
• Treatment: 018 STEELCORE GUIDE WIRE; 035 JSTIFF TERUMO WIRE; 6FR SHEATH; PERCLOSED PROGLIDE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male