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

Catalog Number	S-55-060-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Malposition of Device (2616)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Exemption number e2019001.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately calcified, mildly tortuous superficial femoral artery (sfa) and popliteal artery.After crossing the lesion with an unspecified 0.014 system and non-abbott intravascular ultrasound catheter, the physician performed pre-dilatation using a non-abbott 5x40mm balloon dilatation catheter (bdc) and a non-abbott 6x40mm bdc.After confirming the diameter, the guide wire was switched for a command 18 guide wire.The 5.5x60mm supera self expanding stent system (sess) was deployed in the popliteal artery.However, during deployment, the deployment lock was unlocked, and before entirely advancing the thumb slide, the proximal end of the stent jumped out from the sheath, which made the distal part of the stent seem slightly elongated.The stent was implanted, and another 6x40mm supera stent was deployed in the proximal sfa with no issues.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: returned device analysis identified a missing separated ratchet ear, but the account did not note this separation at any point.There was no resistance noted during advancement or resistance.It is unknown if the separated ratchet ear remains inside the patient anatomy.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 received.Investigation is not yet complete a follow-up report will be submitted with all additional relevant information.Code 2199 was removed.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The deployment difficulties and stent elongation were unable to be confirmed as the stent was already deployed and not returned.The separation of the ratchet ear was confirmed.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 revealed no other complaints.The investigation was unable to determine a cause for the reported difficulties.Additionally, a cause for the separated portion of the ratchet ear and relation to the reported deployment issue was unable to be determined.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: 9152519
• Report Number: 2024168-2019-12335
• Device Sequence Number: 16817842
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/03/2020

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 Expiration Date: 10/31/2020
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 8113061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/30/2019; 12/12/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/21/2019; 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND 18 GUIDE WIRE
• Outcome Attributed to Adverse Event: Other