MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-60-120-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a chronic total occlusion in the heavily calcified, mild tortuosity and severely stenosed right superficial femoral artery.Using a retrograde approach, access was obtain in the left femoral, and pre-dilation was performed with an unspecified 6mm balloon.The 6.0 x 120 mm supera self expanding stent system (sess) was advanced over an unspecified 0.014 guide wire.Resistance was noted during advancement due to the patient anatomy.The stent was deployed at the target lesion yet elongated, and migrated to the common femoral artery where a calcium rock was present.In an attempt to avoid the calcium rock, the stent was attempted to be retracted back onto the delivery system, yet resistance was noted due to the heavy calcification.The stent further migrated to the calcium rock causing the stent to further elongate through a bifurcation at the iliac where a prior stent was implanted and ended in the proximal iliac artery.In addition, the nose cone of the supera sess separated in the iliac artery and was retrieved using a snare.The patient was transferred to a higher level care facility for vascular endarterectomy and stent removal by surgical cut down.The patient was discharged the next day.No additional information was provided.
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 incidents from this lot.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that resistance was met with the heavily calcified, mild tortuosity and severely stenosed anatomy resulting in the reported difficult to advance.During attempted deployment, due to the heavily calcified, mild tortuosity and severely stenosed anatomy the stent elongated and inadvertently migrated to the common femoral where a calcium rock was present.In an attempt to retract to stent back into the delivery catheter interaction with the heavily calcified anatomy resulted in the reported difficult to remove where the stent further migrated and elongated.Interaction and/or manipulation of the compromised device ultimately resulted in the reported tip material separation.As reported, the patient was transferred for vascular endarterectomy and stent removal by surgical cut down.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.Reportedly, during advancement resistance was noted due to the heavily calcified, mild tortuosity and severely stenosed anatomy.It should be noted that the supera peripheral stent system instructions for use states: precaution: should unusual resistance be felt at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.H6: medical device problem code 2017 clarifier- against resistance.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19723909
• Report Number: 2024168-2024-08177
• Device Sequence Number: 12830692
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: (01)08717648211836(17)251130(10)3121161
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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: 11/30/2025
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 3121161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED 0.014 GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female