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

Model Number S-45-040-120-P6

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.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 complaints reported from this lot.Based on the information provided, a definitive cause for the migration could not be determined.It may be possible that the migration was related to anatomical conditions or the vessel diameter larger than the 4.5mm diameter of the supera stent; however, this could not be confirmed.The foreign body in patient was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified superficial femoral artery (sfa).Pre-dilatation was performed with a 5mm balloon.A 4.5x40mm supera stent was advanced to the lesion and once deployed a control injection was made, when it was noted that the stent began moving down and stopped moving in the mid/proximal portion of the popliteal artery (non-target lesion).A second supera stent was implanted in the sfa where it was long enough that it overlapped with the migrated stent in the popliteal, however, it was confirmed that there was nothing externally done to treat the migrated stent.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: 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: 10775098
• MDR Text Key: 214307316
• Report Number: 2024168-2020-09142
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225925
• UDI-Public: 08717648225925
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: S-45-040-120-P6
• Device Catalogue Number: S-45-040-120-P6
• Device Lot Number: 0012961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 80