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

Model Number S-65-080-120-P6

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported tip detachment was confirmed.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 revealed no other incidents and/or complaints reported from this lot.The reported patient effect of embolism is listed in the supera instruction for use (ifu) as a known potential patient effect associated with the use of the device.The investigation was unable to determine a cause for the tip detachment resulting in embolism and unexpected medical intervention.It may be possible that the tip detachment occurred due to not retracting the thumbslide to sheath the tip and locking the system lock prior to removal causing the tip to catch on the stent and/or anatomy resulting in separation during removal; however, this could not be confirmed.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 performed to treat a target lesion in the left proximal superficial femoral artery (sfa) to external iliac artery, via the right common femoral artery.A 6.0 x 45 non-abbott sheath was advanced up and over to the target lesion.Pre-dilatation was performed using a 5.0 x 80 mm dilatation catheter over a 0.018 guide wire.Additional dilatation was performed using a drug coated balloon.The 6.5 x 80 mm supera stent delivery system was advanced without issue to the target lesion and deployed without issue.After stent deployment, it was noted that the nose cone had detached.A 6.0 x 20 mm non-abbott dilatation catheter was advanced, in an attempt to embed the nose cone into the vessel wall; however, the nose cone embolized to a small branch of the profunda artery.The separated nose cone remains in the patient anatomy and there are no plans to remove it.The procedure ended with the patient in stable condition.There was no clinically significant delay.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: 11924871
• MDR Text Key: 263472815
• Report Number: 2024168-2021-04609
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226267
• UDI-Public: 08717648226267
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: S-65-080-120-P6
• Device Catalogue Number: S-65-080-120-P6
• Device Lot Number: 9111961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• 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
• Patient Age: 66 YR
• Patient Weight: 62