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

Model Number	S-55-060-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported this was a procedure to treat a heavily calcified and heavily tortuous superficial femoral artery.A supera peripheral stent 5.5x60 was inserted without issues and deployed at the target lesion.However, while removing the delivery catheter, the tip became caught on the stent and dislodged from the device.It was also noted that the stent had become dislodged as well.Therefore, the physician decided to insert a snare and remove the stent.It was then observed that the tip of the delivery catheter had migrated and become embedded in the calcium of the aorta.The tip of the delivery catheter was no longer mobile; therefore, the physician decided to leave it in the anatomy.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.The lot history record 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 investigation was unable to determine a conclusive cause for the reported difficulties.It is possible the heavily calcified and heavily tortuous superficial femoral artery contributed the reported difficulties.It may be possible that the tip was not retracted and locked in place prior to removal causing interaction with the stent and/or anatomy resulting in separation and dislodgement; however, this could not be confirmed.The additional treatment was due to case circumstances.The reported embolism and foreign body in patient are additional circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture.H10; initially the device was to be returned.

• 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: 11445694
• Report Number: 2024168-2021-01855
• Device Sequence Number: 3618777
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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