MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number	S-65-040-120-P6
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to procedural circumstances.It is likely that the distal sheath of the delivery system was entrapped or bent in the anatomy such that the ratchet was unable to engage the stent properly resulting in the deployment difficulty.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 this was a percutaneous intervention (pci) treating a previously placed non-abbott stent that had fractured, located in the left superficial femoral artery (sfa).Pre-dilatation was performed using a 7.0x20mm mustang balloon and a supera stent delivery system (sds) was selected due to the desired radial strength.The supera sds advanced to the previously implanted stent without reported issues.During deployment, the stent had stopped ratcheting and was no longer deploying.Standard troubleshooting was performed; the supera handle was rotated and re-positioned upwards.The supera stent had then continued to deploy without further issues.The supera stent was implanted in the intended area without stretching observed.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9331221
• Report Number: 2024168-2019-13642
• Device Sequence Number: 1927684
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2019

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: 05/31/2021
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 9061861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1