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

Catalog Number	S-50-040-120-P6
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that a deployment issue was noted with a 5.0 x 40 mm supera self-expanding stent system (sess).No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.The investigation was unable to determine a cause for the reported difficulty.It may be possible that anatomical conditions contributed to the difficulty; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 9131748
• Report Number: 2024168-2019-12184
• Device Sequence Number: 2475717
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 11/19/2019

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: 10/31/2020
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 8111961
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1