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

Catalog Number	S-50-060-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional 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 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.It should be noted that the supera instruction for use instructs: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.In this case, failing to use fluoroscopy during removal does not appear to have caused the difficulty.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the popliteal artery with heavy calcification and no tortuosity.The vessel diameter was 4-5mm and a 6f 45 cm introducer sheath was placed.A 5.0x60 mm supera self expanding stent system (sess) was deployed and imaging confirmed stent deployment at the target lesion.The handle was fully retracted and locked and the sess was removed from the anatomy without significant resistance.On removal of the sess from the patient's anatomy it was noted that the stent remained attached to the end of the delivery system.The delivery system was not removed under fluoroscopy.An additional 5.0x60mm supera stent was deployed successfully to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7798773
• Report Number: 2024168-2018-06374
• Device Sequence Number: 10793167
• Product Code: NIP
• UDI-Device Identifier: 08717648211744
• UDI-Public: 08717648211744
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: S-50-060-120-P6
• Device Lot Number: 8032761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 99