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

Catalog Number 42065120-080

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2020

Event Type  malfunction  

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.

Event Description

It was reported that during an intervention, the 6.5x120mm supera peripheral self-expanding stent (ses) was advanced to the lesion and implanted.It was noted that the length of the stent was significantly longer than the size information on the package.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device as well as review of the provided angiographic images.The stent was not received.The reported oversized stent length was unable to be confirmed.A ruler was used to measure the returned self expanding stent catheter length, the length was 80 cm; the stent length marker was measured, and it was 120 mm.The measurements obtained match the pouch/chipboard box label information.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 complaints reported from this lot.An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images provided.The investigation was unable to confirm the reported oversized supera stent.Based on the returned device evaluation of the super stent system and review of the provided images, the assumption that an incorrect stent length of 150 mm cannot be confirmed by the user provided measurement.Initial review of this image show that the proximal portion of the measurement line starts proximal to the actual proximal stent edge at what is estimated to be at least 15 mm.Subtracting this assumed measurement error provides an estimated net length of 135 mm for the deployed stent.In addition, when reviewing the clear reduced diameter of the stent at the overlap junction the mechanical properties of the woven stent come into play.All things being equal, when a section of the supera stent is compressed below its nominal diameter, adjacent areas of the stent proximal and distal to that compression site compensate and increase the net length of the stent.Additionally, there are clear areas of additional elongation which compound any elongation created at the overlap and would require additional stacking beyond the amount needed to compensate for the overlap elongation.Taken in total the stent appears to be a 120 mm stent that was deployed with an initial elongation, as well as subsequent elongated portions that were not completely mitigated by sufficient stacking throughout the deployment length.Overall, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3: date of event.D6a: implant date.

Event Description

Subsequent to the initial report, the following information was received: the procedure was to treat a heavily calcified mid-distal superior femoral artery (sfa).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
• MDR Report Key: 11092111
• MDR Text Key: 224858330
• Report Number: 2024168-2020-11003
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 42065120-080
• Device Lot Number: 9101561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1