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

Catalog Number UNK SUPERA

Device Problems Stretched (1601); Difficult or Delayed Activation (2577); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The reported resistance, difficult activation, material deformation and stretch could not be confirmed.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation could not determine the cause for the reported resistance, difficult activation, material deformation and stretch.It is possible the ratchet did not release immediately from the stent due to the procedure circumstances during retraction of the ratchet, causing the activation difficulty and deformation, however, this could not be confirmed.The additional therapy was due 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 performed to treat a heavily calcified, mildly tortuous superficial femoral artery.Pre-dilatation was done with a 4mm and 5mm balloon.Three supera stents were implanted (two 4.5x120mm and one 4.5x150mm).During deployment of the supera stent (unknown which one) using a 6f sheath (10cm) and a 0.018" non-abbott guidewire, the deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle.Resistance was felt with the thumbslide, but the stent was ultimately deployed.The stent became invaginated and stretched.Post-dilatation was done with good results.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: UNKNOWN SUPERA
• 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: 11029101
• MDR Text Key: 222091227
• Report Number: 2024168-2020-10657
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 2 SUPERA; GUIDEWIRE: TORX 0.018
• Patient Outcome(s): Required Intervention