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

Catalog Number	S-55-040-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
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 returned.Visual inspections were performed on the returned device.The tip detachment was confirmed.The difficulty removing and resistance was unable to be tested as it was based on circumstances of the procedure.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 investigation was unable to determine a cause for the reported the tip detachment.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 located in the popliteal that was described as fibro-calcific.After placement of a 6fr x 55 cm sheath, the vessel was prepped per supera instructions for use.Predilatation was performed on the 5 mm vessel with an armada balloon catheter.A 5.5 x 40 supera peripheral self-expanding stent system (sess) was advanced through the sheath against resistance, then to the lesion.The stent was deployed without difficulty and was fully released.The thumbslide was confirmed to be in the locked position and the delivery system was withdrawn with slight resistance felt with the deployed stent resulting in the nose cone / tip separating in the vessel.The nose cone / tip was successfully retrieved using a snare device.There were no adverse patient sequelae.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: 6877215
• Report Number: 2024168-2017-07592
• Device Sequence Number: 13577042
• Product Code: NIP
• UDI-Device Identifier: 08975370026283
• UDI-Public: 08975370026283
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 6031861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR