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

Catalog Number S-45-080-120-P6

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Device Damaged by Another Device (2915); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

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 if the device is returning for analysis.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a moderately calcified lesion in the left proximal popliteal and left superficial femoral artery.A supera stent was implanted without issue.A second supera self-expanding stent system was then advanced to deploy the stent proximally to the previously implanted stent; however, [during deployment] the supera stent overlapped the previously implanted stent due to the stent size and both stents became caught and were pulled back.The stents released from each other and the supera sheath was attempted to be pulled back; however, the supera stent had not been properly pushed out [fully deployed] from the delivery system and the stent was dragged across the bifurcation during device removal.The patient was then taken to surgery, and a surgical cut down was performed to remove the stent from the right iliac.The first deployed supera stent remained in the target lesion.The procedure concluded after the surgical cut down and no additional treatment was provided for the target lesion.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 2915 labeled.Internal file number - (b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported failure to deploy, entrapment of device, difficulty to remove and device damaged by another device (caused damage) was unable to be replicated in a testing environment as it was based on operational 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 similar incidents reported for this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: the implanted stent was a 4.5x120mm supera.The second stent used was a 4.5x80mm supera.The second supera stent pulled back the previously implanted supera stent from the target lesion.Both stents were surgically removed from the patient.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: 8176246
• MDR Text Key: 130773485
• Report Number: 2024168-2018-09824
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 8071761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: SUPERA
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR