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

Catalog Number	S-65-060-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2016
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.Concomitant products: guide wire: glide wire, magic torque, platinum plus exchange, stabilizer plus; guide cath: 5 fr aquatempo.The device was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported deployment issue.The additional therapy was due to case circumstances.A review of the job traveler for this product could not be performed and the historical data for the reported lot could not be reviewed because the product was not returned for evaluation and the lot number was not reported.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 mildly calcified lesion in the peroneal artery.A supera stent was advanced toward the target lesion and the stent was implanted.Post dilatation was performed due to stent mal-apposition.Additional treatment was required due to a perforation caused by a non-abbott guide wire in the left peroneal artery.Two unsuccessful attempts were made to seal a perforation by inflating a balloon.A 3.5x19mm graftmaster stent system was advanced toward the target lesion.The system was inflated up to 12 atmospheres, the stent was implanted and the perforation was successfully sealed.There was no adverse patient sequela and no reported 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: 5976132
• Report Number: 2024168-2016-06415
• Device Sequence Number: 16318049
• Product Code: NIP
• UDI-Device Identifier: 08975370026351
• UDI-Public: (01)08975370026351
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2016

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-65-060-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2016
• Initial Report FDA Received Date: 09/25/2016
• 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: 75 YR