MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM

Model Number S-60-100-120-P6

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/26/2016

Event Type  Injury  

Event Description

A peripheral case to re-vascularize the left leg of a (b)(6) male in the cardiac cath lab on (b)(6) 2016 resulted in retained foreign bodies.During the case a supera stent manufactured by abbott was deployed and the tip dislodged.After multiple attempts, the tip was unable to be retrieved.There were two further deployments needed and the same effect of the tip dislodging occurred.One tip was able to be retrieved and the other two remained in the left leg.The sheath was left in place and pt transferred to isu for close observation.On (b)(6) 2016, the pt ws discharged without compromise of circulation of left leg to follow up for retrieval with vascular surgeon.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SUPERA PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 5409614
• MDR Text Key: 37548388
• Report Number: MW5059988
• Device Sequence Number: 1
• Product Code: NIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: S-60-100-120-P6
• Device Lot Number: 5082761
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR