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

Model Number	S-60-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Unspecified Tissue Injury (4559)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a left superficial femoral artery.The lesion was predilated with 5.0x80mm and 5x150mm non-abbott balloons.The 3.0x120mm supera self-expanding stent system (sess) was deployed; however, during removal under fluoroscopy the nose cone separated inside the sheath and the stent was pulled back with the sess.The patient became hypotensive and a femostop was used to apply pressure to the access site as during removal of the supera it created a lager hole.It was noted the thumbslide was not slid all the way back.The patient was sent to the intensive care unit (icu).There were no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
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.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure including expansion failures was unable to be replicated in a testing environment due to the condition of the returned device.The reported material separation was able to be 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 identified no other incidents from this lot.The reported patient effect of hypotension is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.Reportedly, it was noted the thumbslide was not slid all the way back.It should be noted that the supera peripheral stent system instructions for use states: following confirmed implantation of the supera stent, retract the thumbslide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal the thumbslide was not slid all the way back, thus during withdrawal the nose cone interacted with the deployed stent resulting in the reported activation/deployment failure and ultimately resulting in the reported/noted material separations (tip, inner member).The reported/noted difficulties possibly resulted in the reported hypotension however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure as a femostop was used to apply pressure to the access site as during removal of the supera it created a lager hole.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 12910904
• Report Number: 2024168-2021-10936
• Device Sequence Number: 17343640
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 05/31/2023
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 1062461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 83 KG