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

Catalog Number	S-55-150-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with heavy calcification and no tortuosity.A 6french (f) sheath was used and the vessel diameter size was 5.5mm.The vessel was prepared using a balloon and an intravascular lithotripsy (ivl) catheter.No atherectomy was used.A 5.5x150mm supera self-expanding stent system (sess) was deployed without issues.Another 5.5x150mm supera sess was advanced and was being deployed; however, when about 30mm left could not completely deploy the stent.There was no resistance with the thumbslide but it felt like the ratchet was not grabbing or pushing at all.The deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle.The introducer sheath was not close at all to the proximal end of the stent during deployment.No portion of the stent was deployed inside the introducer.To complete the deployment of the stent, the shaft was pulled as the thumbslide was advancing which elongated the proximal portion of the stent a bit but was implanted, however, the stent was not measured.The delivery system was removed under fluoroscopy.A nitinol stent was implanted at the proximal part of the sfa due to the elongation.Upon removal, it was noted that the shaft looked twisted but the physician was not twisting the delivery system at all.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material twisted / bent was able to be confirmed.The reported difficult or delayed activation and the reported stretched stent was unable to be replicated in a testing environment due to the condition of the returned device (stent previously deployed in anatomy).Electronic lot history record (elhr) and exception 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.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling and/or interaction with the heavily calcified anatomy resulted in the noted device damages (sheath tear, twisted catheter shaft) such that during stent deployment the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulties.Manipulation of the compromised device by pulling the shaft as the thumbslide was advanced resulted in the stent to slightly stretch during full stent deployment.As reported, a nitinol stent was implanted at the proximal part of the sfa due to the elongation.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: 18817850
• Report Number: 2024168-2024-02636
• Device Sequence Number: 4342402
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: (01)08717648226168(17)250630(10)3071261
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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: 06/30/2025
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 3071261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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: 014 GLIDEWIRE ADVANTAGE; 5.5X150MM SUPERA STENT; 6F SHEATH; SHOCKWAVE IVL CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female