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

Device Problem Break (1069)

Patient Problems Ischemia (1942); Pain (1994); Stenosis (2263)

Event Date 11/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi#: in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.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.The reported patient effects of ischemia, pain, and restenosis are listed as potential patient effects associated with the use of the device and are listed in the supera instruction for use.The investigation was unable to determine cause for the reported stent fracture and subsequent patient effects.It may be possible that the supera stent was subjected to stress, fatigue or repetitive movement due to anatomical conditions or location of the stent; however, this could not be confirmed.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 on (b)(6) 2018 to treat chronic totally occluded lesion in the distal superficial femoral artery (sfa) and popliteal.The patient was symptomatic approximately four weeks prior to the procedure, and had presented with critical ischemia / peripheral arterial disease stage 3 with pain at rest.During the procedure, it was discovered that a supera stent had already been implanted in the patient in approximately 2015.The stent was located partially in the popliteal and partially in the distal sfa, and was occluded due to restenosis and broken in the p-1 segment.A non-abbott self-expanding stent graft was used to treat the restenosis and broken portion of the supera stent.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Hospitalization added to outcomes attributed to adverse event.

• 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
• MDR Report Key: 8166351
• MDR Text Key: 130458564
• Report Number: 2024168-2018-09723
• Device Sequence Number: 1
• Product Code: NIP
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

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
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention