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

Catalog Number 42065060-080

Device Problems Difficult to Remove (1528); Stretched (1601); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a calcified, eccentric, 30 mm, 90% stenosed lesion in the right popliteal, artery.The vessel diameter was 6.5 mm and atherectomy was not used.The lesion was prepared with a 7x40 mm armada percutaneous transluminal angioplasty (pta) catheter at 18 atmospheres for 1 minute.The 6.5x60 mm supera self expanding stent (ses) was deployed without issue.At the end of the stent it was noted that the tip of the delivery system was stuck to the stent.Additionally a 7x40 mm armada 35 pta catheter became stuck when it was attempted to be removed.The armada was managed to be removed with mechanical manipulation by rotating and pushing the device.The stent became elongated and was pulled upwards, completely away from the target lesion due to the interaction with the delivery system and the armada.Additional stents had to be placed at the distal and proximal ends of the supera.There were no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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.The armada 35 catheter referenced is filed under a separate medwatch report number.

Event Description

N/a.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to remove and the reported stent migration were unable to be replicated in a testing environment as they were based on operational circumstances.The reported stretched stent was unable to be confirmed as the stent was not returned.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the deployed stent as the tip/nose cone was being retracted resulted in the reported difficult to remove.Manipulation of the device resulted in the reported stretched stent and the reported stent migration.Manipulation of the device and/or interaction with other devices likely resulted in the noted device damages (stretched tip jacket, stretched inner member).The treatment appears to be related to the operational context of the procedure as additional stents had to be placed at the distal and proximal ends of the supera.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: 14625032
• MDR Text Key: 293851494
• Report Number: 2024168-2022-06061
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 07/28/2022

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: 10/31/2023
• Device Catalogue Number: 42065060-080
• Device Lot Number: 1111661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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: 0.018¿¿ COMMAND ST 210CM; 23CM CORDIS BRITE TIP 6F SHEATH; ARMADA 35 7X40 MM
• Patient Outcome(s): Required Intervention