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

Model Number	S-55-080-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - estimated.Implant date - estimated.The stent remains implanted and will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other two supera stents mentioned are filed under separate mfr report numbers.
Event or Problem Description
It was reported through a research article, identifying the supera peripheral stent system as follows: in (b)(6) 2019, patient presented with bilateral intermittent claudication (rutherford classification.A 5.5x80mm and a 6.0x80mm supera self-expanding stent and two non-abbott stents were implanted in the right superficial femoral artery (sfa).A 5.5x120mm supera stent, along with two non-abbott stents were implanted in the left superficial femoral arteries, resolving the intermittent claudication.Six months after stent implantation, the patient experienced intermittent claudication and was hospitalized.In-stent restenosis (isr) was observed at the supera stent sites.Balloon angioplasty was performed and stents were implanted resolving the restenosis and claudication.Details are listed in the article, titled clinical performance of polymer-coated paclitaxel-eluting stent implanted for diffuse and calcified superficial femoral artery stenotic lesions: insights from a patient on hemodialysis.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of restenosis is listed in the supera instructions for use, as a known potential patient effect associated with the use of the device.In this case, there was no reported device malfunction associated with the supera self-expanding stent system (sess).Based on the case information, 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.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12277653
• Report Number: 2024168-2021-06830
• Device Sequence Number: 14572105
• Product Code: NIP
• UDI-Device Identifier: 08717648226106
• UDI-Public: 08717648226106
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: S-55-080-120-P6
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 8082761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELUVIA POLYMER-COATED PACLITAXEL-ELUTING STENT; OTHER IMPLANTED SUPERA STENTS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR