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

Model Number	S-50-100-120-P6
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional supera device referenced is being filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a 100% stenosed, chronic totally occluded, and moderately calcified de novo lesion in the right superficial femoral artery.On (b)(6) 2019, a 5.0x120mm and 5.0x100 supera self-expanding stents were implanted with a 3mm overlap.About one week post-procedure, the patient felt discomfort with pain and cold at the tip of their right foot.On (b)(6) 2019, an x-ray confirmed that the stents had moved and were no longer overlapping.A 5x60mm non-abbott stent was successfully deployed at the section were the supera stents had previously overlapped.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported patient effect of pain is listed as a potential adverse effect of peripheral percutaneous intervention and is listed in the supera instruction for use.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.Based on the information provided, a conclusive cause for the reported stent migration and subsequent patient effects could not be determined.It may be possible that location of the stent implant in conjunction with anatomical conditions and/or repetitive movement contributed to the stent migration; however, this could not be confirmed.The additional treatment and hospitalization are due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9446894
• Report Number: 2024168-2019-14359
• Device Sequence Number: 2242481
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: S-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 8111261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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: 5.0X120MM SUPERA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention