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

Catalog Number S-55-150-120-P6

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/14/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly calcified, 99% stenosed lesion in the left superior femoral artery (sfa).The lesion was pre-dilated with a 5.0x100 balloon distal to the sfa near a previously implanted stent.The 5.5 x 150 supera self-expanding stent system (sess) was advanced without issue.The slide was switched to release the stent and the nose cone was recaptured, but the user did not realize that the supera stent never released from the sess.The sess was pulled back and this inadvertently pulled the stent into the left common femoral artery and then into the external iliac artery.It was realized that the stent was stuck on the catheter and would not release.He pulled the device back to the original access site and at that point the stent dislodged into the left to right iliac arteries and was free floating.They attempted to embed the stent when the nose cone broke off and was lodged inside the sheath.The patient was sent to the operating room for bilateral cut downs where the sheath and nose cone were successfully removed.The stent was unable to be removed from the anatomy therefore two non-abbott stents were used to embed the supera across the bifurcation into the aorta to the common iliacs.The procedure was ended at that point.The patient was ultimately okay.No replacement was used for the supera stent as the procedure was ended after it was embedded.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

Subsequent to the initially filed report, the following information was received: medwatch form -(b)(4).The device was hard to use.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported dislodged stent was unable to be confirmed due to the condition of the returned device.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 did not indicate a lot specific quality issue.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 the distal sheath of the delivery system was entrapped or bent in the mildly calcified and 99% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulty/activation failure.Manipulation of the device resulted in the noted device damages (multiple sheath bends/kinks) likely contributing to the reported difficulties.Further interaction/manipulation of the device as the device was pulled back to the sheath resulted in the reported dislodged stent and ultimately resulted in the reported tip separation/noted tip jacket and inner member separations.The treatment(s) appears to be related to the operational context of the procedure as reportedly the sheath and nose cone were successfully removed, and two non-abbott stents were used to embed the supera across the bifurcation into the aorta to the common iliac.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment medwatch report#(b)(4).

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: 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: 17392823
• MDR Text Key: 319742965
• Report Number: 2024168-2023-07990
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 3042661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female