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

Model Number S-50-120-120-P6

Device Problems Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

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

Event Date 11/02/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the mildly calcified, mildly tortuous, 90% stenosed, superficial femoral artery.The lesion was 5 mm, atherectomy was not used and the lesion was prepared with a 5 mm balloon inflated to 8 atmospheres for 3 minutes.The 5.0x120 mm supera self expanding stent system (sess) could not release the stent after two thirds of deployment; however the stent was ultimately deployed.Then the delivery system was removed through the sheath and the stent was severely stretched during the forced removal.The stent remains partially in the target lesion and partially in healthy tissue and is stretched.Finally a stent of the same size was deployed at the target lesion.There were no reported adverse patient sequela and there was no clinically significant delay in the procedure.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.

Event Description

It was reported that the procedure was to treat the mildly calcified, mildly tortuous, 90% stenosed, superficial femoral artery.The lesion was 5 mm, atherectomy was not used and the lesion was prepared with a 5 mm balloon inflated to 8 atmospheres for 3 minutes.The 5.0x120 mm supera self expanding stent system (sess) could not release the stent after two thirds of deployment; however the stent was ultimately deployed.Then the delivery system was removed through the sheath and the stent was severely stretched during the forced removal.The stent remains partially in the target lesion and partially in healthy tissue and is stretched.Finally a stent of the same size was deployed at the target lesion.There were no reported adverse patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report it was confirmed that the second stent was used to treat the uncovered portion of lesion and not to treat the stretched stent.No additional information was provided.

Manufacturer Narrative

B1: product problem.D9: device is not returning.H1: malfunction.H6 health effect impact code 4641 was removed.The device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

N/a.

Manufacturer Narrative

The device was not returned for analysis.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, the 5.0x120 mm supera self expanding stent system (sess) could not release the stent after two thirds of deployment; however the stent was ultimately deployed.Then the delivery system was removed through the sheath and the stent was severely stretched during the forced removal.It should be noted that the supera peripheral stent system instructions for use states: should unusual resistance be felt at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during stent deployment interaction with the mildly calcified, mildly tortuous and 90% stenosed anatomy resulted in the ratchet being unable to properly engage/fully deploy the stent; thus resulting in reported difficult or delayed activation.During removal interaction with the sheath resulted in the reported difficult to remove and the reported stretched 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: 12829668
• MDR Text Key: 280894557
• Report Number: 2024168-2021-10484
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 1031161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 11/19/2021; 12/15/2021
• Supplement Dates FDA Received: 12/10/2021; 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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