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

Model Number S-50-120-120-P6

Device Problems Activation Failure (3270); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Only the stent was received.The delivery system was not returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the procedure was to treat a lesion in the heavily calcified, heavily tortuous right superficial femoral artery (rsfa).The 5.0 x 120 mm supera stent system was advanced in the patient anatomy without resistance.The stent was deployed without issue.Under fluoroscopy it was noted that the stent had migrated from the rsfa to the internal iliac.It was also noted that part of the stent was in the introducer sheath.It is unclear if the introducer sheath pulled the stent into the internal iliac or if the stent migrated on its own.The introducer sheath was used with a guide wire and an nc trek balloon dilatation catheter to fully pin the stent inside the introducer sheath and the devices were removed together, with the stent pinned inside the introducer sheath.There was no adverse patient effect or a clinically significant delay in the procedure.Two supera stents were implanted without further issue successfully completing the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned stent.Since only the stent implant was returned, the deployment issue and migration could not be confirmed.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 indication of a lot specific product quality issue.The investigation determined that the reported difficulties were likely related to circumstances of the procedure.Based on the reported information, it appears that the stent had partially deployed into the introducer sheath, and as the sheath was removed, the stent migration occurred.It is likely that there was inadequate distance between the introducer sheath and stent during deployment causing the stent to partially deploy in the sheath.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
• MDR Report Key: 10713214
• MDR Text Key: 212349969
• Report Number: 2024168-2020-08805
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211775
• UDI-Public: 08717648211775
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: S-50-120-120-P6
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 0010761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH: DESTINATION; INTRODUCER SHEATH: DESTINATION
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 65