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

Catalog Number SE-06-100-080-6F

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is unknown at this time if the device is returning.A follow up report will be submitted with all relevant information.

Event Description

It was reported that tip of an unknown supera self-expanding stent system (sess) separated post deployment of the stent.The sess was removed without the tip.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The tip detachment was confirmed.The resistance was not confirmed as it was related to case circumstances.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 other incidents.The removal procedure section of the supera instruction for use instructs: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.In this case, it is likely that failing to retract the thumbslide and lock the system lock contributed to the tip detachment.The investigation determined that the tip detachment was likely attributed to user error.It is likely that failing to retract the thumbslide and lock the system lock contributed to the resistance and tip detachment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

Subsequent to the initially filed report, the following information was received: it was reported that the procedure was to treat a stenotic de novo lesion in the superficial femoral artery with no tortuosity and heavy calcification.The lesion was pre-dilatated to 6 atmospheres for two minutes with a 7.0x100 armada 35 balloon dilatation catheter.The 6.0x100 mm supera self expanding stent system (sess) was advanced to the lesion through a 6f introducer sheath without resistance.Fluroscopy confirmed that the stent of the sess was fully deployed and the system was removed under fluoroscopy.The thumb slide of the sess was not fully retracted and locked prior to withdrawal.The sess was withdrawn from the patient anatomy against resistance with force.The tip of the sess separated and was retrieved using a snare.There was no adverse patient sequela and no clinically significant delay in the procedure.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
• MDR Report Key: 7583026
• MDR Text Key: 110509037
• Report Number: 2024168-2018-04322
• 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,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: SE-06-100-080-6F
• Device Lot Number: 7092161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6F
• Patient Outcome(s): Other; Required Intervention