MAUDE Adverse Event Report: AV-VR-MENLO-PARK 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	10/24/2016
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.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported failure to deploy.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 identified no other incidents from this lot.Based on the information reviewed, 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 heavily calcified, unspecified lesion.There was resistance deploying the last part of a 5.5 x 40 mm supera stent and it could not release from the 6f sheath so the sheath and stent were removed from the anatomy together.The procedure was completed with balloon angioplasty.There was no clinically significant delay in procedure and no adverse patient effects.There is no additional information at this time.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-VR-MENLO-PARK; abbott vascular; 3885 bohannon drive; menlo park CA 94025
• MDR Report Key: 6108158
• Report Number: 2024168-2016-08021
• Device Sequence Number: 287607
• Product Code: NIP
• UDI-Device Identifier: 08975370026283
• UDI-Public: (01)08975370026283(17)180630(10)6071961
• Combination Product (Y/N): N
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2016

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: 06/30/2018
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 6071961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR