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

Model Number	S-45-060-120-P6
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during device preparation of a 4.5x60mm supera self-expanding stent system (sess), the device was being flushed when the tip became separated.The sess was not used for the procedure.There was no patient involvement and no clinically significant delay in the procedure.A 5x80mm absolute pro self-expanding stent system (sess) was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during flushing/preparation for use resulted in the noted device damages (shaft torn/kinked, stretched inner member) and ultimately resulted in the reported tip separation.D9, h3: device was received.H6: component code 4755 - removed.H6: type of investigation code 4114 - removed.H6: investigation findings code 213 - removed.H6: investigation conclusions code 67 - removed.
Additional Manufacturer Narrative
The device was not returned for analysis.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 incidents from this lot.It is possible that inadvertent mishandling during flushing/preparation for use resulted in the reported tip separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14018110
• Report Number: 2024168-2022-03594
• Device Sequence Number: 4610072
• Product Code: NIP
• UDI-Device Identifier: 08717648225949
• UDI-Public: 08717648225949
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: S-45-060-120-P6
• Device Catalogue Number: S-45-060-120-P6
• Device Lot Number: 1071361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 04/20/2022; 07/08/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/06/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown