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

Catalog Number 42045120-120

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

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 revealed no other incidents and/or complaints reported from this lot.Based on the information provided, the reported deployment difficulty appears to be due to case circumstances.It is likely that there was inadequate distance between the introducer sheath and stent during deployment causing the proximal end of the stent to deploy in the sheath.The additional treatment to release the stent from the introducer sheath was due to circumstances of the procedure.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 very complex, heavily calcified, chronic total occlusion (cto) from the superior femoral artery (sfa) to the proximal popliteal.After a 4.5x120mm supera stent was deployed, it was noted that approximately 5mm of the proximal part of the stent had deployed inside the 45cm, 7fr non-abbott, introducer sheath.An unspecified balloon was used to push the stent through the sheath, and it was successfully deployed in the target lesion.The delivery system was removed from the patient under fluoroscopy, without complications.The patient recovered pulse in the posterior tibial artery.There was no adverse patient sequela and no reported clinically significant delay in the procedure.There was no additional information provided regarding this issue.

• 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: 10849342
• MDR Text Key: 216829941
• Report Number: 2024168-2020-09594
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DR
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 42045120-120
• Device Lot Number: 0021761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2020
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 79