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

Catalog Number 42065120-120

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part number and lot number were not provided.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in superficial femoral artery and popliteal artery.Three supera self-expanding stent systems (sess) (a 5.50x200mm, a 6.50x100mm and a 6.50x120mm) were advanced and the stents implanted in the procedure.The first two supera stents were deployed without issue.However, the third supera stent was being advanced over the same non-abbott guidewire (gw) and difficulty was noted.The guidewire was observed to be kinked.The physician attempted to manipulate the tip of the sess in order to advance the sess on the wire; however, was unable to advance the sess.Therefore, the gw was replaced with another non-abbott gw.The third supera sess was advanced over the new gw without issue and the stent was deployed.However, during the last overview xray of the procedure the tip of the sess was noted to have broken off in the patient; therefore a snare device was used to remove the tip.Additionally, thrombus was noted in the vessel.There was no adverse patient sequela and no clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.Additionally returned device analysis noted that the tip was kinked and the tip jacket was kinked.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.The reported patient effect of thrombosis is listed in the supera peripheral stent systems instructions for use (ifu) as a potential adverse effect of peripheral percutaneous intervention.Reportedly, the supera was being advanced over the same non-abbott guidewire (gw) and difficulty was noted.The guidewire was observed to be kinked.The physician attempted to manipulate the tip of the sess in order to advance the supera on the wire; however, was unable to advance the supera.It should be noted that the supera peripheral stent system ifu states: 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.The force applied seemed to be a reasonable clinical response to the difficulties.Additionally, reportedly, the delivery system was not removed under fluoroscopy.It should be noted that the supera peripheral stent system ifu states: under fluoroscopy remove the device from the guide wire and evaluate the improved luminal quality of the treated area.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.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 resistance was met with the reported kinked guide wire resulting in the reported difficult to advance.Manipulation of the device likely compromised the device such that after the guide wire exchange interactions and/or further manipulation of the device resulted in the noted device damages (tip kink, tip jacket kink) and ultimately resulted in the reported tip separation/noted tip jacket and inner member separations.The reported difficulties possibly contributed to the reported patient effect; however, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure as a snare device was used to remove the tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: health effect - clinical code 4582 - removed.

• 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: 15801851
• MDR Text Key: 303701922
• Report Number: 2024168-2022-11629
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 42065120-120
• Device Lot Number: 1120261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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
• Treatment: 5.5X200MM SUPERA STENT.; 6.5 X 120 MM SUPERA STENT.; 6.50X100MM SUPERA STENT.
• Patient Outcome(s): Required Intervention