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 Problem Stenosis (2263)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.The udi is unknown because the part number and lot number were 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 were not provided.The reported patient effect of stenosis is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment 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 additional adverse events listed in the article (summary data and additional two patient cases) are being filed under separate medwatch report #s.Article, titled "use of the helical supera¿ stent and passeo-18 lux¿ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the arch v supera-lux study".

Event Description

This event was identified thru review of an article stating in the case study of a (b)(6) year-old female it was reported that the procedure was to treat a left brachiocephalic fistula that had a previously implanted supera stent.Two months post stenting it was noted recurrence of cephalic arch stenosis (cas) causing access dysfunction.The cas was treated with high pressure plain balloon angioplasty followed by a non-abbott drug coated balloon.Persistent in-stent restenosis resulted in further treatment with drug coated balloon at 4, 9, 10 and 12-months post target procedure date.Specific patient information is documented as unknown.Details are listed in article titled "use of the helical supera¿ stent and passeo-18 lux¿ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the arch v supera-lux study".

• 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: 12527526
• MDR Text Key: 273170881
• Report Number: 2024168-2021-08560
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 09/24/2021

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: 09/20/2021
• Initial Date FDA Received: 09/24/2021
• 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: 76 YR