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

Catalog Number 42045030-120

Device Problems Break (1069); Premature Activation (1484); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported two supera stents were implanted however the tips of both stents were broken off.No additional information was provided.

Manufacturer Narrative

D4: the udi is unknown due to the part/lot number was not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional supera device referenced in b5 is filed under separate medwatch report number.Na.

Event Description

Subsequent to the initially filed reports, additional information was provided: it was reported the procedure was to treat a highly tortuous and calcified arteria mesenterica inferior.The lesion was pre-dilated with a 3mm balloon.The 4.50x30mm supera self expanding stent system (ses) was advanced with resistance noted with the introducer sheath.The stent was deployed successfully.During removal, the thumb-slide was not fully retracted to the start position.Resistance was met with the anatomy and the tip of the ses detached.A second supera of the same size was advanced however could not pass through the first implanted stent.During removal resistance was met and the tip separated and the stent came out of the sheath.The stent was able to be removed.Attempts were made to snare both separated tips but were unsuccessful and the tips remain in the patient anatomy.No additional information was provided.

Manufacturer Narrative

B1: adverse event selected.B2: added required intervention.D4: updated part and lot numbers from unknown to 42045030-120 and 3042761.D4: updated expiration date.H1: updated type of event from malfunction to serious injury.H4: added device manufacture date.H6: codes 4582, 2199, 1069 removed, codes 2687, 4641, 1562, 2524, 1528, 1484, and 2017 added device code 2017: failure to follow steps.

Event Description

Subsequent to the initially filed reports, additional information was provided: it was reported the procedure was to treat a highly tortuous and calcified arteria mesenterica inferior.The lesion was pre-dilated with a 3mm balloon.The 4.50x30mm supera self expanding stent system (ses) was advanced with resistance noted with the introducer sheath.The stent was deployed successfully.During removal, the thumbslide was not fully retracted to the start position.Resistance was met with the anatomy and the tip of the ses detached.A second supera of the same size was advanced however could not pass through the first implanted stent.During removal resistance was met and the tip separated and the stent came out of the sheath.The stent was able to be removed.Attempts were made to snare both separated tips but were unsuccessful and the tips remain in the patient anatomy.No additional information was provided.

Manufacturer Narrative

B5 - describe event or problem: updated d4 - lot # updated from unknown to 3042761 the device was returned for analysis.The reported premature activation and the reported material separation were able to be confirmed.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.Reportedly, the supera device was advanced however could not pass through the first implanted stent.It should be noted that the supera peripheral stent system instructions for use states: when placing multiple stents, the most distal stent should be placed first (if possible), followed by placement of the proximal stent.Stenting in this order eliminates the need to cross and reduces the chance of dislodging stents which have already been placed.As the deviation of the instructions for use appears to have caused/contributed to the reported difficulties the deviation will be addressed in the account requested letter.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that during attempted advancement through the previously implanted stent (against the instructions for use) interaction with the previously deployed stent resulted in the reported failure to advance.During removal, interaction with the previously deployed stent and/or the highly tortuous and calcified resulted in the reported difficult to remove.Manipulation of the compromised device resulted in the stent to inadvertently deploy and ultimately resulted in the reported/noted tip material separation.As reported, attempts were made to snare the separated tip but were unsuccessful and the tip remains in the patient anatomy.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 18825321
• MDR Text Key: 336748295
• Report Number: 2024168-2024-02677
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648224850
• UDI-Public: (01)08717648224850(17)250331(10)3042761
• 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,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42045030-120
• Device Lot Number: 3042761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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