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

Catalog Number S-60-150-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Malposition of Device (2616); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.Visual and functional analysis was performed on the returned device.The reported partial deployment, mechanical jam of the thumbslide, difficult to remove, stent elongation and malposition of the stent could not be confirmed or replicated due to the condition of the returned device, as the stent was already fully deployed.The tip separation as well as damage to the distal sheath were confirmed.The investigation determined that the reported difficulties were most likely related to case circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other complaints reported from this lot.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 chronic total occlusion (100% occluded) in the moderately calcified superficial femoral artery (sfa) was predilated with a 6.0x200 mm armada 18 balloon dilatation catheter at 8 atmospheres two or three times.The 6.0x150 mm supera stent was advanced to the sfa target lesion and stent deployment commenced.After approximately 4 cm of the supera stent was deployed, the thumbslide became stuck and was no longer able to be actuated.It was decided to remove the partially deployed stent.During removal of the stent delivery system, the tip of the self expanding stent system became detached and the thumbslide became unstuck.Approximately another 2 to 3 cm of the stent deployed and the sess could no longer be retracted into the 6 french sheath.It was decided to deploy the stent where it was in the unintended area across the iliac/aortic bifurcation.The stent was elongated by about 25% but it was ok.No additional information was provided.

• Brand Name: SUPERA PERIPHERAL 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: 9597030
• MDR Text Key: 178350527
• Report Number: 2024168-2020-00733
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 9021961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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
• Patient Outcome(s): Other