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

Model Number	S-60-060-120-P6
Medical Device Problem Codes	Product Quality Problem (1506); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the tyvek pouch on a 6.0x60mm supera self-expanding stent system separated too quickly during opening and caused the product to fall.There was no patient involvement.The procedure was successfully completed with a new 6.0x60mm supera stent.There was no clinically significant delay in the procedure.No additional information was provided.The return device analysis identified that the tyvek pouch was torn from the upper left-hand side down to the bottom right hand side.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported complaint was unable to confirmed or replicated in a testing environment as it was based on operational circumstances.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 revealed no other similar incidents.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the technique used to open the pouch was too fast and/or was pulled apart roughly resulting in the pouch opening to quickly causing the tear on the pouch and the device falling to the ground.Additionally, based on the returned analysis of the pouch, no anomalies were noted on the vendor or abbott seals.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9481447
• Report Number: 2024168-2019-14613
• Device Sequence Number: 208945
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 07/31/2021
• Device Model Number: S-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 9081361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1