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

Catalog Number 42075100-120

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a popliteal aneurysm in a mildly tortuous vessel in the superficial femoral artery.The aneurysm had a diameter of 3 cm.During release of the 7.5x100mm supera self expanding stent (sess) under fluoroscopy, the white arrow tip of the shaft was noted to have separated.There was resistance during advancement.As the shaft was removed, there was resistance and it was noted that the stent slipped up [dislodged] to the proximal end.The thumb slide was fully retracted to the start position and both the system and deployment levers locked prior to removal.After removal of the sess under fluoroscopy, the physician saw the white arrow tip remained in the arteria fibularis.Attempts in removing the separated tip failed and remained in the side branch of the arteria fibularis.The aortic bifurcation was normal.There was no guide wire resistance or other device interaction.Atherectomy was not used.There was no waste noted to the deployed stent or proximal end of the lesion.The physician had to perform a cut down to eliminate the aneurysm.The patient was still in hospital which is normal practice.There was a clinically significant delay in the procedure but the patient is doing well.No additional information was provided.

Manufacturer Narrative

(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.

Manufacturer Narrative

The device was returned for analysis; however, due to the returned condition and stent was not returned, the reported dislodgement, difficult to advance, and difficulty removing could not be tested.The reported material separation was able 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 there was no reported 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 mildly torturous anatomy and/or other devices resulting in the reported difficult to advance.During removal the tip likely interacted with the deployed stent resulting in the reported difficult to remove.Manipulation of the device resulted in the noted device damages (stretched/kinked inner member) and ultimately resulted in the reported tip material separation.In addition, interaction/manipulation of the compromised device likely resulted in the reported stent dislodgement.The treatment appears to be related to the operational context of the procedure.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: 14603795
• MDR Text Key: 293367971
• Report Number: 2024168-2022-05994
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 42075100-120
• Device Lot Number: 1080261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2021
• 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
• Patient Outcome(s): Required Intervention