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

Catalog Number 42055100-120

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

H6- medical device problem code 2017: failure to follow steps/instructions.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 lot number was not provided.The reported patient effect of occlusion is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.Reportedly, the vessel diameter was 4mm.Pre-dilatation was performed using a balloon.The 5.5x100mm supera self-expanding stent system (sess) was implanted and the physician oversized the stent by 1mm but got too elongated, greater than 10% of the expected length.It should be noted that the supera peripheral stent system instructions for use states: measure the vessel / duct diameter (proximal and distal to the lesion / stricture).Select a stent with a labeled diameter equal to the vessel / duct reference diameter.The deviation of the instructions for use appears to have caused/contributed to the reported difficulties.The investigation determined the reported stretched stent appears to be related to deviation of the instructions for use as it is likely that oversizing the stent by 1mm resulted in the stent to stretch/elongate greater than 10% of the expected length.The reported difficulties possibly contributed to the reported patient effects, however a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure as reportedly the patient had to get his leg amputated as the popliteal was noted to be occluded by the supera stent implant.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the right superficial femoral and popliteal artery with moderate calcification.The vessel diameter was 4mm.Pre-dilatation was performed using a balloon.The 5.5x100mm supera self-expanding stent system (sess) was implanted and the physician oversized the stent by 1mm but got too elongated, greater than 10% of the expected length.The patient refused a second procedure.About 2 months after the first procedure, angiography was performed and the patient had to get his leg amputated as the popliteal was noted to be occluded by the supera stent implant.Occlusion was confirmed to be not thrombosis.There was no adverse patient sequelae.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• 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: 17393620
• MDR Text Key: 319865905
• Report Number: 2024168-2023-08020
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42055100-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/25/2023
• 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; Disability; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Hispanic