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

Catalog Number	S-65-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2019
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.Evaluation summary: visual and dimensional inspections were performed on the returned device.The deployment issue and stent elongation were not confirmed as the stent was returned fully deployed.Additionally, a tip detachment was noted during the returned analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.A review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported deployment issue.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 superficial femoral artery.An unspecified supera stent was deployed without issue at the lesion.Then a second 6.5x100mm supera stent was planned for implant.The physician pushed the thumbwheel fully forward and had assumed that the supera stent had deployed fully at the lesion.However, the stent only partially deployed, still part of it inside the catheter.The physician then pulled the catheter for removal when resistance was noted with the introducer sheath.The physician then realized the supera stent had only been partially deployed.The sheath with the stent was removed altogether as a single unit.Once outside of the anatomy, it was noted that the supera stent had stretched.A new sheath and non-abbott stent was used to successfully complete the procedure.There were no 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: 8422583
• Report Number: 2024168-2019-02030
• Device Sequence Number: 18907938
• Product Code: NIP
• UDI-Device Identifier: 08717648226281
• UDI-Public: 08717648226281
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/14/2019

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: 07/31/2020
• Device Catalogue Number: S-65-100-120-P6
• Device Lot Number: 8082861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 73