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

Model Number S-65-080-120-P6

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577)

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

Event Date 12/06/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.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 the left common femoral artery (cfa).The cfa had a vessel diameter of 6.5x7.5mm and the external iliac artery was 6.5x6.7mm.The vessel was prepared by using a 7.0x70mm balloon with a nominal pressure of 6atmospheres (atms) for a total of 3 minutes.Atherectomy was used.The 6.5x80mm supera self-expanding stent system (sess) advanced without resistance and seemed to be deploying fine and the thumbslide was put back in the original position and locked properly.It was confirmed under fluoroscopy that the stent emerged from the sheath and was fully released.Upon removal of the sess under fluoroscopy, the physician noticed the stent was pulling back into the sheath, however, the stent was able to be released from the system.The system was pulled out with no resistance noted.The physician went back in with a sheath dilator and was able to manipulate the sheath and the dilator and get the proximal portion of the stent off of the sheath.The dilator was then removed.During removal of the sheath, the physician only pulled back a couple of centimeters (cm) and took some images.The physician then removed the wire and it was then noticed that a portion of the delivery system, which was the tip, came with the with wire.There was no adverse patient effect.Although there was reported delays in the procedure, it was confirmed that there were no adverse patient effects; therefore the delay is not considered clinically significant.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 or delayed activation was unable to be replicated in a testing environment 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 identified no other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal the catheter tip inadvertently got caught on the deployed stent resulting in the reported difficult or delayed activation.Manipulation of the compromised device ultimately resulted in the reported tip material separation/noted inner member and tip jacket separations.The treatment appears to be related to the operational context of the procedure as the physician went back in with a sheath dilator and was able to manipulate the sheath and the dilator and get the proximal portion of the stent off of the sheath.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: 16045800
• MDR Text Key: 306153337
• Report Number: 2024168-2022-13079
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 2031061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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: .014 HT COMMAND WIRE; R2P TERUMO 6FRENCH SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 55 KG