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

Catalog Number 42055150-080

Device Problems Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous in the popliteal artery.For vessel preparation a shockwave device was used and followed by a unspecified dilatation catheter balloon.The 5.5x150mm supera self-expanding stent system partially deployed 5-6 centimeters; however, the thumbslide was rotated about 30-40 times, but the stent would not deploy further.The second safety lock was open and able to deploy 1 cm more of the stent.It was noted that the ratchet inside the shaft that delivers the stent was not working properly.The supera delivery system and stent were attempted to be removed under fluoroscopy; however, the tip of the stent separated and was removed via snare.However, a portion of the device separated (maybe the plastic connection from the shaft to the tip) remained inside the patient.An attempt to snare that separated portion was made, but unsuccessful.An absolute pro was used to push the remaining small separated portion into the arterial wall.Final result was satisfactory; however, clinically significant delay was noted.No additional information was provided.

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.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The tip separation was confirmed.The stent separation and mechanical jam were not confirmed.The activation failure could not be tested due to the condition of the 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 identified no other related incidents.The investigation could not determine the cause of the reported difficulties.In this case, the ratchet ears may have sheared, and it is possible the undeployed stent caught the tip during removal separating the tip, however, these cannot be confirmed.The additional therapy and foreign body in patient and delay were due to case circumstances.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: 15681756
• MDR Text Key: 302503450
• Report Number: 2024168-2022-11089
• Device Sequence Number: 1
• Product Code: NIP
• 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
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 42055150-080
• Device Lot Number: 0120761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• 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: SHORT 7F SHEATH
• Patient Outcome(s): Required Intervention