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

Catalog Number S-50-080-120-P6

Device Problems Difficult or Delayed Positioning (1157); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.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 similar incidents from this lot.Additionally, it was reported that resistance was felt against the guide wire and force was applied against resistance when advanced to the target lesion.It should be noted that the supera instruction for use (ifu) states: should unusual resistance be felt at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.The investigation was unable to determine a conclusive cause for the reported resistance, deployment issue and inaccurate delivery.The delay in procedure was due 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.

Event Description

It was reported that after pre-dilating the lesion with an unspecified 4.0mm diameter balloon dilatation catheter (bdc), then a 5.0mm diameter bdc, a 5.0mm x 80mm x 120cm supera peripheral stent system was advanced over an unspecified guide wire to treat a lesion in the right superficial femoral artery (sfa).Resistance was felt against the guide wire and force was applied against resistance when advanced to the target lesion.During deployment, the supera thumb advancer was initially difficult to rotate, but was able to be completely rotated without resistance after the initial difficulty.During deployment, the stent reportedly jumped distally by 60mm, resulting in deployment of only 20mm in the distal target lesion, with the remaining 60mm deployed in distal healthy vessel tissue.The supera delivery system was withdrawn without difficulty, followed by withdrawal of the unspecified guide wire.As the guide wire was noted to be kinked (due to advancement difficulty), another guide wire was advanced, followed by advancement and deployment of another supera stent (5.5mm x 150mm x 120cm) without issue, overlapping the 1st deployed supera and successfully covering the remaining proximal lesion segment.While there were no adverse patient sequelae, this issue caused a clinically significant delay.No additional information was provided.

• 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: 5792762
• MDR Text Key: 49540727
• Report Number: 2024168-2016-04553
• 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
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 5111761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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