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

Model Number S-60-150-120-P6

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified superficial femoral artery that was 100% stenosed.The procedure was performed via contralateral approach with a non-abbot 5f sheath.Per the physician as there was a previously implanted stent in the common femoral artery, a smaller diameter sheath (5f) was thought as best to use as much as possible for this procedure.After a 0.014 gw crossed, pre-dilatation was performed with a 6x150mm non-abbott balloon.Then a 6x150mm supera was advanced to the lesion and deployment initiated, however, the deployment lock was not unlocked.Approximately 2cm of the stent was deployed, but the thumbslide became unable to be pushed.Therefore, stent deployment did not proceed any further.The delivery system was removed as a single unit.Then the sheath was replaced with 6f sheath and after the gw crossed, a non-abbott stent was deployed to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.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 mildly tortuous, heavily calcified superficial femoral artery that was 100% stenosed.The procedure was performed via contralateral approach with a non-abbot 5f sheath.Per the physician as there was a previously implanted stent in the common femoral artery, a smaller diameter sheath (5f) was thought as best to use as much as possible for this procedure.After a 0.014 gw crossed, pre-dilatation was performed with a 6x150mm non-abbott balloon.Then a 6x150mm supera was advanced to the lesion and deployment initiated, however, the deployment lock was not unlocked.Approximately 2cm of the stent was deployed, but the thumbslide became unable to be pushed.Therefore, stent deployment did not proceed any further.The delivery system was removed as a single unit.Then the sheath was replaced with 6f sheath and after the gw crossed, a non-abbott stent was deployed to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, the account provided additional information: during removal of the supera device, resistance was met with the non-abbott sheath.Additional information received by the account confirms that the physician never reached the step of unlocking the deployment lock as the thumbslide would not slide at all from the start.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation/deployment failure, the reported mechanical jam and the reported difficult to remove were 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 did not indicate a lot specific quality issue.Reportedly, the procedure was performed with a non-abbot 5f sheath.It should be noted that the supera peripheral stent system instructions for use states the minimum sheath compatibility is 6f.The deviation of the ifu likely caused/contributed to the reported difficult to remove.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 and subsequent deviation of the instructions for use as it is likely that interactions with the mildly tortuous, heavily calcified and 100% stenosed anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system; thus resulting in reported activation/ deployment failure and the reported mechanical jam.During removal interaction with the undersized sheath resulted in the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.H6 medical device problem code 2017- failure to follow steps / instructions was 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: 15382595
• MDR Text Key: 301020605
• Report Number: 2024168-2022-09501
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 1091061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2021
• 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: PARENT SELECT 5F (MEDIKIT); SHIDEN 6*150 MM