MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915)

Patient Problem Thrombosis (2100)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was discarded.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) 2017 a supera stent was deployed a lower extremity vessel.Post dilatation was performed.Following, the stent pulled back into an unintended area within the vessel.Per physician, this was possibly due to the post dilatation balloon and there was no device malfunction.The stent was re-advanced back into proper position.Less than a week later, the stent had thrombosed and was removed via a percutaneous intervention on (b)(6) 2017.Visual inspection did not reveal any deformities of the stent.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).The udi# is unknown because the part number and lot number was not provided.The device was not returned for analysis.However, it is likely that the difficulties and subsequent patient effects are the results of interaction with the balloon catheter during post-dilatation.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.It should be noted that the reported patient effect, thrombosis, is listed in the supera instructions for use (ifu) as known potential adverse patient effect.The investigation determined the reported difficulties were due to operational context.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 STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7290894
• MDR Text Key: 100759881
• Report Number: 2024168-2018-01334
• Device Sequence Number: 1
• Product Code: NIP
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/06/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR