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

Catalog Number S-60-150-120-P6

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a percutaneous intervention treating multiple very heavily calcified, chronic total occlusion (cto) lesions, located in the mid to distal superficial femoral artery (sfa) and to the popliteal artery.Balloon angioplasty was performed in the sfa.Following, a supera stent advanced to the sfa containing a previous dissection.During supera advancement, resistance was noted due to the heavily calcified anatomy.Stent deployment was initiated.About 50 mm of the stent deployed when thumbslide resistance was noted.The thumbslide was extremely difficult to rotate and about 1/3 of the stent was still located in the sheath.Stent deployment continued while stacking the stent.Carefully, the stent was fully implanted in the intended area with slight elongation and with some stent stacking.There were no adverse patient effects and there was no clinically significant procedural delay.There was no additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported difficulties were unable to be confirmed as the stent had already been fully deployed.Based on the reported information, it is likely that the difficulties were the result of the challenging anatomical conditions.Reportedly, the resistance advancing was due to the heavy calcification.Additionally, the resistance noted with the thumbslide during deployment and the slight elongation and stacking of the stent was likely the result of the distal shaft being restricted within the tight lesion.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific product issue.The investigation determined the reported difficulties were due to case circumstances.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: 6530695
• MDR Text Key: 74096268
• Report Number: 2024168-2017-03771
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 5102761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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