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

Catalog Number UNK SUPERA

Device Problems Device Damaged by Another Device (2915); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

The stent remains in patient.The stent delivery system will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a non-abbott filter was being used and the 6.5x150 mm supera self expanding stent (ses) was implanted in a distal position.Reportedly, the supera ses was implanted over the wire of the filter.Another non-abbott stent was deployed proximal to the supera ses and was meant to overlap but it could not be overlapped because the wire was trapped in a strut of the supera ses.Post dilatation was attempted but the balloon could not advance due to the trapped wire.After deployment of the 2 stents it was attempted to retrieve the filter; however due to the wire being stuck in the stent, the filter could not be retrieved.Snare was attempted to retrieve the filter but was not successful.Ultimately the physician was able to pull the filter and wire out, but this caused slight migration of the supera stent.Nothing remains in the patient.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

D4.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.The stent migration was the result of the supera stent being implanted over the wire of the non-abbott filter causing difficulty retrieving the filter and migration of the supera stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Event Description

Subsequently to the initially filed report, the following information was provided: the procedure was to treat the mildly calcified, non tortuous, right superficial femoral (sfa) artery.The vessel diameter was 5.5-6.0 mm and was prepared with balloon angioplasty with 1 inflation for 2-3 minutes.It was further reported that it was a 5.5x150 supera stent that was implanted.There was 15 minutes delay in continuing the procedure; however, there was no impact to the patient.Buddy wire and the retrieval catheter were also attempted to remove the filter and wire.75% of the stent is in the target lesion and 25% is in healthy tissue.No additional information was provided.

• Brand Name: UNKNOWN SUPERA
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10938866
• MDR Text Key: 219324945
• Report Number: 2024168-2020-10140
• Device Sequence Number: 1
• Product Code: NIP
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPIDER FILTER; SPIDER FILTER