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

Model Number S-60-120-120-P6

Device Problems Entrapment of Device (1212); Material Separation (1562); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2021, a percutaneous peripheral intervention was performed on the left superficial femoral artery (sfa) lesion.A shockwave (6.060mm) and regular 4.0x40mm balloon catheter up to 12 atmospheres prepped the vessel.A supera stent delivery system advanced to the treatment site without issue.At the end of stent deployment, which had been successful, without issues, it was observed that the tip (nose cone) was stuck on the deployed stents strut.The fully deployed stent was deployed at the intended location, however, due to the tip being caught on the stent strut, and during delivery system removal attempt, the stent had then moved to an unintended, non-target location.The tip had subsequently separated from the delivery catheter.All was left in place and the patient was taken for surgery.The separated tip and stent were removed during surgery.There was no adverse patient sequela.No additional information was provided regarding this issue.

Manufacturer Narrative

The device was returned for analysis.The reported separation was confirmed.The entrapment of the device was not tested due to the device condition.The stent migration was not tested due to the involvement of the anatomy.There is additional noted damage to the tip jacket and stretches to the jacket and tip lumen.The noted break and stent damage are likely contributed to procedural circumstances.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 similar incidents reported from this lot.The investigation was unable to determine a cause for the reported tip detachment.It may be possible that the tip detachment was due to not retracting the thumbslide to the sheath tip and locking the system lock prior to removal resulting in the tip catching the stent struts resulting in separation; however, this could not be confirmed.Subsequently the tip and stent had migrated due to these procedural circumstances.The noted damages to the tip lumen and stent damage are likely due to the removal of the delivery system and challenging anatomy.The additional treatment to remove the tip and stent was related to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 12033240
• MDR Text Key: 257383322
• Report Number: 2024168-2021-05195
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 9111461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR