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

Model Number	S-50-040-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional supera device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a de novo, mildly calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The vessel diameter was 5.0mm.Pre-dilatation was not performed and atherectomy ws not used.Because there was lesion at both (left and right) vessel, puncture was done antegradely from left sfa and a 5.0x80mm supera self expanding stent system (sess) was implanted at left sfa.Then, approach was changed to cross-over approach technique, total occluded lesion at right popliteal vessel was attempted to be treated.A guide wire was attempted to cross the lesion, but it failed to cross.When the last fluorography was done, dissection at left sfa was noted.The 5.0x40mm supera sess was implanted to treat the dissection but the stent became elongated [stretched] because of no pre-dilatation.There was no resistance during advancement.Post-dilatation was performed to treat the dissection.However, it was noted that the tip of the sess had separated and remained in the patient's body floating freely distal of the stent at sfa but no blood flow distal of p1.The thumb slide was not fully retracted to the start position and both the system and deployment levers were not locked prior to removal.The physician did not rotate the system lock and the deployment lock into the locked position (in line with the thumb slide).The delivery system was removed without fluoroscopy.The aortic bifurcation was at the usual angle.The patient condition was not stable since the patient's age was in the 90's and the procedural time was long.The procedure was completed with decision that the remained tip will be removed when amputation surgery is performed at a later day because there was no blood flow distal to the lesion which was a pre-existing condition.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional supera device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a de novo, mildly calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The vessel diameter was 5.0mm.Pre-dilatation was not performed and atherectomy ws not used.Because there was lesion at both (left and right) vessel, puncture was done antegradely from left sfa and a 5.0x80mm supera self expanding stent system (sess) was implanted at left sfa.Then, approach was changed to cross-over approach technique, total occluded lesion at right popliteal vessel was attempted to be treated.A guide wire was attempted to cross the lesion, but it failed to cross.When the last fluorography was done, dissection at left sfa was noted.The 5.0x40mm supera sess was implanted to treat the dissection but the stent became elongated [stretched] because of no pre-dilatation.There was no resistance during advancement.Post-dilatation was performed to treat the dissection.However, it was noted that the tip of the sess had separated and remained in the patient's body floating freely distal of the stent at sfa but no blood flow distal of p1.The thumb slide was not fully retracted to the start position and both the system and deployment levers were not locked prior to removal.The physician did not rotate the system lock and the deployment lock into the locked position (in line with the thumb slide).The delivery system was removed without fluoroscopy.The aortic bifurcation was at the usual angle.The patient condition was not stable since the patient's age was in the 90's and the procedural time was long.The procedure was completed with decision that the remained tip will be removed when amputation surgery is performed at a later day because there was no blood flow distal to the lesion which was a pre-existing condition.No additional information was provided.
Additional Manufacturer Narrative
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 similar incidents and/or complaints from this lot.The supera instructions for use instructs: prepare the vessel / duct utilizing standard angioplasty technique using a balloon size greater than the stent outer diameter.Additionally, the removal procedure section states: ¿following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.¿ in this case, failing to pre-dilate the vessel as well as failing to retract and lock the thumbslide into place prior to removal appears to be the likely cause for the reported difficulties.Based on the information provided, the reported difficulties and subsequent patient effects appear to be user/case related.Failing to pre-dilate the vessel as well as failing to retract and lock the thumbslide into place prior to removal appears to be the likely cause for the reported difficulties.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: 13061564
• Report Number: 2024168-2021-12058
• Device Sequence Number: 19811527
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 12/31/2022
• Device Model Number: S-50-040-120-P6
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 1010561
• 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: 12/06/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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: SUPERA 5.0X80MM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown