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

Catalog Number 42055060-120

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Difficult to Advance (2920)

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

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

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 heavily calcified, heavily tortuous popliteal artery that is 95% stenosed.The vessel was pre-dilated with an unspecified 5mm balloon at rate burst pressure for one minute.The 5.5x60mm supera self-expanding stent system (sds) was advanced with resistance noted with anatomy.During deployment of the stent, it was noted that the catheter tip separated in the patient.The sds was removed under fluoroscopy with resistance noted with anatomy.The patient was sent to another hospital where a cut down was performed to successfully remove the separated portion and the deployed stent.The deployed stent was removed as it had elongated due to the calcified lesion.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported tip material separation was able to be confirmed.The reported difficult to advance and difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.The reported stretched stent was unable to be confirmed as the stent was 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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, heavily tortuous and 95% stenosed anatomy resulting in the reported difficult to advance and the reported difficult to remove.During stent deployment and removal interaction with the heavily calcified, heavily tortuous and 95% stenosed anatomy resulted in the reported stretched stent and ultimately resulted in the reported/noted tip material separation and the noted inner member separation.As reported, a cut down was performed to successfully remove the separated portion and the deployed stent.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: 16469073
• MDR Text Key: 310528726
• Report Number: 2024168-2023-02120
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42055060-120
• Device Lot Number: 2090761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention