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

Catalog Number	S-55-040-120-P6
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a calcified, stenosed and short segment occlusion of the sfa to the proximal popliteal artery.A 6fr guide catheter placed followed by a.014 command guide was advanced without issue then intravascular ultrasound was performed.A 4.0x40mm balloon dilated the lesion and the guide wire was changed to a.018 non-abbott guide wire with the advancement of 5.5x40mm supera stent.The stent was deployed; however, stent without sufficient expansion and invagination occurred.Therefore, the stent was explanted using a.014 wire and a 7mm snare catheter.A new 5.5x40mm supera stent was placed and post dilatated with a 5x40mm balloon.A non-flow limiting dissection was noted at the proximal portion of the stent; however, after the balloon dilatation it was confirmed, without residual stenosis and procedure completed.
Additional Manufacturer Narrative
G2: literature added.Attachment: article title removal method of a supera interwoven stent invaginated during its implantation in endovascular procedure: a case report.
Event or Problem Description
It was reported that the procedure was to treat a calcified, stenosed and short segment occlusion of the sfa to the proximal popliteal artery.A 6fr guide catheter placed followed by a.014 command guide was advanced without issue then intravascular ultrasound was performed.A 4.0x40mm balloon dilated the lesion and the guide wire was changed to a.018 non-abbott guide wire with the advancement of 5.5x40mm supera stent.The stent was deployed; however, stent without sufficient expansion and invagination occurred.Therefore, the stent was explanted using a.014 wire and a 7mm snare catheter.A new 5.5x40mm supera stent was placed and post dilatated with a 5x40mm balloon.A non-flow limiting dissection was noted at the proximal portion of the stent; however, after the balloon dilatation it was confirmed, without residual stenosis and procedure completed.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.It is possible that during initial deployment the diameter of the stent used was inadvertently undersized for the size of certain parts of the calcified, stenosed and occluded vessel; thus resulting in the reported patient-device incompatibility wall apposition; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility wall apposition cannot be determined.As reported, the stent was explanted using a.014 wire and a 7mm snare catheter resulting in the reported stent material deformation.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19280932
• Report Number: 2024168-2024-05703
• Device Sequence Number: 12660694
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: (01)08717648226069(17)240831(10)2090161
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 08/31/2024
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 2090161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 05/13/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/09/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male