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

Model Number	S-55-060-120-P6
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with 90% stenosis, mild calcification and no tortuosity.The vessel size was between 5-6mm in diameter and a 5.0x60mm armada 18 balloon was inflated from 8-14 atmospheres (atms) without issues.Atherectomy was used.The 5.5x60mm supera self-expanding stent system (sess) was advanced to the target lesion.The access site was the right groin.The introducer sheath was about 10-11cm to the proximal end of the stent during deployment.The deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle.However, the stent only partially deployed when there was a thumbslide issue and would not deploy further.There was no portion of the stent that deployed inside the introducer.The system was removed and the stent was flowered upon removal but there were no complications.An absolute pro stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be 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 identified no other incidents from this lot.As the reported mechanical jam and the reported activation failure were unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal sheath of the delivery system was entrapped or bent in the mildly calcified and 90% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in difficulty advancing the thumbslide/ mechanical jam and the reported deployment difficulty/activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with 90% stenosis, mild calcification and no tortuosity.The vessel size was between 5-6mm in diameter and a 5.0x60mm armada 18 balloon was inflated from 8-14 atmospheres (atms) without issues.Atherectomy was used.The 5.5x60mm supera self-expanding stent system (sess) was advanced to the target lesion.The access site was the right groin.The introducer sheath was about 10-11cm to the proximal end of the stent during deployment.The deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle.However, the stent only partially deployed when there was a thumbslide issue and would not deploy further.There was no portion of the stent that deployed inside the introducer.The system was removed and the stent was flowered upon removal but there were no complications.An absolute pro stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified biological materials noted on the stent.There were additional biological materials noted on the ratchet ears and stem.The account confirmed there was no vessel damage.No additional information was provided.

• 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: 16843657
• Report Number: 2024168-2023-04485
• Device Sequence Number: 6823170
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 2050261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.018 COMMAND GUIDE WIRE.; 6FR SHEATH.
• Patient Sex: Unknown