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

Catalog Number	S-50-080-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record for this lot revealed no nonconforming material records.The reported patient effect of occlusion is listed in the supera instructions for use as a known potential patient effect associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effect, 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.The other additional supera devices referenced in b5 and d11 are being filed under a separate medwatch report number.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported that the procedure was performed to treat a non-tortuous, non-calcified superficial femoral artery.Three supera stents (5.0x80mm, 5.0x60mm, and 5.5x120mm) and a non-abbott stent were successfully placed in the lesion.Blood flow was limited as only a trickle was noted through the stents.A blockage was suspected but unable to identify or confirm as thrombus.Bypass surgery was done as treatment.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: SUPERA PERIPHERAL 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: 8962094
• Report Number: 2024168-2019-11438
• Device Sequence Number: 2768658
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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 Catalogue Number: S-50-080-120-P6
• Device Lot Number: 8081661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/04/2019
• 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: 5.0X60MM SUPERA; 5.5X120MM SUPERA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention