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

Model Number S-50-120-120-P6

Device Problems Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.It should be noted that the supera instruction for use (ifu) states: ¿under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.¿ although the device was removed without fluoroscopy, this did not cause the deployment issue of the stent not fully releasing.Based on the information provided, a conclusive cause for the reported difficulty could not be determined.It is possible that the distal sheath of the supera delivery system was bent or angled in the anatomy such that the ratchet was unable to engage the stent properly preventing full deployment; however, this could not be confirmed.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 the 5.0 mm, non tortuous, mildly calcified right superficial femoral artery (sfa).Atherectomy was performed and the lesion was pre-dilated with a non-abbott 5.0x100 mm balloon.The supera self expanding stent (ses) was advanced and believed to be fully deployed.The delivery system was not removed under fluoroscopy and when it was removed, it was found that the stent was only partially deployed and had been removed with the sheath.An absolute pro ses was deployed to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.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: 10944283
• MDR Text Key: 219518416
• Report Number: 2024168-2020-10170
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 9072561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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
• Treatment: .014 320CM SPIDER FX FILTER WIRE; COOKE RAABE 6F 65CM SHEATH
• Patient Age: 44 YR