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

Catalog Number	S-65-120-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2017
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.Product performance engineering reviewed the incident information; however, it was not possible to perform a thorough analysis on the product because it was not returned to abbott vascular for investigation.The investigation determined the reported failure to deploy to be related to circumstances of the procedure.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot numbers were not provided.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous and heavily calcified superficial femoral artery.A 6.5 x 120 supera stent was being deployed when the guide wire kinked and the sheath moved forward and part of the stent was deployed in the sheath.The devices could not be removed so the patient was sent to surgery where a cutdown was performed to remove the devices there was a clinically significant delay in the procedure and the patient is in good condition.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: 6280413
• Report Number: 2024168-2017-00689
• Device Sequence Number: 1075679
• Product Code: NIP
• UDI-Device Identifier: 08975370026382
• UDI-Public: (01)08975370026382
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

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 Catalogue Number: S-65-120-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 01/26/2017
• 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