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

Model Number S-55-060-120-P6

Device Problems Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

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 heavily tortuous, heavily calcified right superficial femoral artery that was 90% stenosed.To prepare the lesion a 5 mm balloon was used to expand at 6 atmospheres for 1 minute.Then a 5.5x60mm supera stent was advanced to the lesion but could not be released as the vessel was too tortuous.The thumbslide was attempted to be advanced but resistance was met during attempted deployment.The device was removed.It was noted that a portion of the stent deployed inside the introducer sheath.A non-abbott stent was used 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

Visual and functional analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the thumbslide operated properly and the stent was able to be fully deployed during functional testing.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.The investigation determined that the reported difficulties were related to circumstances of the procedure.It is likely that the distal sheath of the delivery system was bent or entrapped within the anatomy preventing the ratchet from engaging the stent properly, resulting in difficulty advancing the thumbslide and difficulty releasing the stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a heavily tortuous, heavily calcified right superficial femoral artery that was 90% stenosed.To prepare the lesion a 5 mm balloon was used to expand at 6 atmospheres for 1 minute.Then a 5.5x60mm supera stent was advanced to the lesion but could not be released as the vessel was too tortuous.The thumbslide was attempted to be advanced but resistance was met during attempted deployment.The device was removed.It was noted that a portion of the stent deployed inside the introducer sheath.A non-abbott stent was used 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 confirmed that there was no portion of the stent deployed inside the introducer sheath as previously reported.No additional information was provided.

• 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: 12804137
• MDR Text Key: 283306569
• Report Number: 2024168-2021-10295
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: 08717648226083
• 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
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 1041461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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: 6F COOK SHEATH