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

Model Number	S-50-080-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as reported inadvertently the stent had been partially deployed in the 6fr sheath; thus resulting in the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The additional supera device is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the distal superficial femoral artery (sfa).A 5mm armada balloon was used for predilatation.The balloon was inflated to 8 atmospheres for the duration of 60 seconds.The 5.0x80mm supera self expanding stent system (sess) was advanced and placed at the target lesion.The stent was deployed, however during removal the stent came out.It was not noted at the time but the stent had been partially deployed in the 6fr sheath.Ultimately, the delivery system and stent were able to be simply withdrawn from the anatomy.Then a 5.0x100mm supera was then placed; however again during removal of the sess, part of the stent was deployed in the sheath.The sheath was then pulled back which exposed the stent and deployment was able to be completed.When the delivery system came out without the nose cone, it was confirmed via fluoroscopy that the nose cone remained stuck at the proximal edge of the implanted stent.Attempts were made to snare the nose cone however were unsuccessful.The patient refused further intervention, therefore the procedure concluded.The flow within the stent implant was not impacted by the nose cone.No additional information was provided.

• 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: 14175548
• Report Number: 2024168-2022-04328
• Device Sequence Number: 15010417
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• 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
• Report Date (Section B): 04/21/2022

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: 02/28/2023
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 1031961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SHEATH
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 106 KG