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

Model Number	S-60-040-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The delivery system is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during a moderately calcified right superficial femoral artery intervention, visibility was poor, but it was felt that the supera stent was deployed without issue; however, during removal of the delivery system, resistance was felt.The stent elongated by about 40% and the nose cone detached.The nose cone was pulled into the sheath with the use of balloons.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The stent was not returned as it was implanted.The reported tip detachment was confirmed.The difficulty removing and stent elongation could not be confirmed as the stent was not returned.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 reported from this lot.The investigation was unable to determine a cause for the reported difficulties.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: 9645232
• Report Number: 2024168-2020-01018
• Device Sequence Number: 1965035
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: 08717648211799
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 06/30/2021
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 9072461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/22/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/14/2020
• 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: Required Intervention