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

Catalog Number 42055200-120

Device Problems Material Separation (1562); Stretched (1601); Difficult or Delayed Activation (2577); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the common femoral to tibial peroneal arteries.The vessel diameter was 5.3-5.5 mm and atherectomy was not used.The lesion was prepared with a 5 mm balloon for 3 minutes at rated burst pressure and a 6 mm balloon for 3 minutes at nominal pressure.The 5.5x200 supera self expanding stent system (sess) was advanced and began to deploy.When one centimeter had been released the physician wanted to move it because it was not placed well but it could not be moved so the stent was released where it was located however it was very elongated.When pulling the catheter, the tip broke and separated from the rest of the catheter.The tip migrated through the vessel and remains in the patient as no retrieval attempt was made.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult/delayed activation and the reported stretched stent was unable to be confirmed due to the condition of the returned device.The reported migration was unable to be replicated in a testing environment as it was based on operational circumstances.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.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 circumstances of the procedure as it is likely that during stent deployment movement of the device/stent resulted in the reported difficult/delayed activation and the reported stretched stent.Interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the reported/noted tip material separation.As reported, the tip migrated through the vessel and remains in the patient as no retrieval attempt was made.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: 16765299
• MDR Text Key: 313537783
• Report Number: 2024168-2023-03972
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42055200-120
• Device Lot Number: 2062061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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
• Treatment: 6FR SHEATH.; V18 GUIDE WIRE.
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 65 KG