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 or Delayed Activation (2577); Defective Device (2588); Difficult to Advance (2920); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat the superficial femoral and popliteal arteries with heavy calcification.The vessel diameter was 6.0 mm and atherectomy was not used.The vessel was prepared with a 7 mm high pressure balloon for 2 minutes.Resistance was noted during advancement with the anatomy.At the start of deployment, after the third advancement of the thumbslide with resistance, the nose cone of the 6.5x120 mm supera self expanding stent system (sess) detached and was retrieved with a snare.The stent was ultimately deployed in the target lesion with some stacking noted in the calcified regions; however there are no concerns with the location or condition of the deployed stent.There were no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6- medical device problem code 2017 clarifier: against resistance.The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported mechanical jam was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult or delayed activation and the reported defective device-shortened were unable to be replicated in a testing environment due to the condition of the returned device/stent not returned.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 from this lot.Reportedly, resistance was noted during advancement with the anatomy.It should be noted the supera peripheral stent system instructions for use (ifu) states: should a sudden increase in resistance be felt at any time during stent system advancement, deployment, or delivery system removal, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components, or damage to the vessel.Additionally: stent placement / deployment states: do not advance the supera peripheral stent system device against significant resistance.The cause of resistance should be determined via fluoroscopy and remedial action taken.The reported deviation of the ifu appears to have contributed to the reported difficulties.A cine was received and reviewed.In conclusion, the images provided do show what appears to be the ¿nose cone¿ (catheter tip) detached from the catheter and located on a portion of the guidewire.Based upon the information provided there is the possibility that the lesion was not prepared sufficiently with the high-pressure balloon prior to the initial delivery of the catheter system as ¿resistance was noted during advancement with the anatomy.This resistance was likely due to incomplete lesion preparation of the reported heavy calcifications.The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that advancing the device against resistance in conjunction with interaction with the heavily calcified, tortuous anatomy resulted in the reported difficult to advance; and thus likely compromised the device such that during stent deployment resulted in the reported difficult/delayed activation/deployment, the reported mechanical jam and ultimately resulted in the reported tip separation.Manipulation of the compromised device to deploy the stent in the heavily calcified anatomy resulted in the reported stent stacking/shortened in the calcified regions.The treatment appears to be related to the operational context of the procedure as the separated nose cone was retrieved with a snare.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16708879
• MDR Text Key: 312971609
• Report Number: 2024168-2023-03647
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42065120-120
• Device Lot Number: 2081861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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: COMMAND 18 GUIDE WIRE.
• Patient Outcome(s): Required Intervention