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

Model Number	S-60-060-120-P6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of stenosis is a known potential patient effect as listed in the supera instructions for use.The investigation was unable to determine a cause for the reported stent fracture and restenosis.It may be possible that severe torquing (material stress/ fatigue) due to repetitive bending of the knee contributed to the fracture; however, this could not be confirmed.The additional therapy/non-surgical treatment and hospitalization are due to operational context of the procedure.There is no indication the issue was caused by, or related to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the popliteal artery.A 6x60mm supera self-expanding stent was implanted on (b)(6) 2017 without issues.On (b)(6) 2018, restenosis was noted in the stent, so an unspecified balloon was used as treatment.On (b)(6) 2020, restenosis was noted, and the stent had fractured into two pieces.An unspecified balloon and a 7x60mm non-abbott stent were used as treatment, and the patient is fine.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10771427
• Report Number: 2024168-2020-09113
• Device Sequence Number: 14484177
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2020

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 Model Number: S-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 95