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

Model Number	S-65-080-120-P6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Analysis is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
Information received via user facility medwatch mw5095203 states: the nose cone of the supera stent broke off into the left external iliac artery.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported tip detachment was confirmed.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 revealed no other complaints.Potential causes for tip detachment include, but are not limited to, anatomical conditions, withdrawal technique, incorrect vessel sizing, and incomplete stent deployment prior to withdrawal, inadequate pre-dilation of the target vessel, manufacturing, or materials related.In this case, a cause for the tip detachment could not be determined with limited information provided.It may be possible that the tip caught introducer sheath or associated devices during advancement.However, this could not be confirmed.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: 10382321
• Report Number: 2024168-2020-06620
• Device Sequence Number: 13922024
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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: 11/30/2020
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 8121361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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