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

Model Number S-55-150-120-P6

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Material Deformation (2976)

Patient Problems Ischemia (1942); Stenosis (2263)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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.Reportedly, during deployment the thumbslide was not advanced to the most distal position.It should be noted that the supera instruction for use (ifu) states: under fluoroscopy, slowly rotate the thumb slide to the most distal position on the handle.It is undetermined if the deviation of the ifu caused/contributed to the difficulties.It is possible that during deployment interaction with the severely calcified anatomy in conjunction with failing to advance the thumb slide to the most distal position resulted in the reported difficulty to deploy and the reported material deformation/ stent invagination; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The reported difficulties possibly contributed to the reported patient effects however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Literature attachment.Article title ¿invagination and restenosis of an interwoven nitinol stent multiple imaging modality findings.¿.

Event Description

It was reported that the procedure on (b)(6) 2020 was to treat an ulcer in a severely calcified right femoropopliteal artery.After pre-dilatation with a 5x80mm non-abbott balloon (18atmospheres (atm), 2minutes (min), 3 times), a 5.5x150mm supera stent was to be implanted.The deployment lock was unlocked and the stent was released, but the thumbslide wasn't advanced to the most distal position during deployment.At the mid-portion of the stent, stent invagination occurred during deployment.The stent was ultimately implanted.After high-pressure balloon dilatation (28 atm, 3 min, twice, 6×40mm non-abbott balloon), final angiography revealed acceptable blood flow to below the knee, but stent invagination was unchanged.Two months later, the patient's ulcer healed completely.However, at 6 months (b)(6) 2020, the patient was symptomatic with the recurrence of the ulcer and critical right limb ischemia.Angiography confirmed 90% restenosis at the mid-portion of the stent, corresponding to the stent invagination.Via intravascular imaging it was noted that the struts had a ¿spider¿s web¿ appearance at the stent invagination and were almost totally covered with large amounts of neointima, leading to lumen loss.Balloon angioplasty with a 6x100mm non-abbott balloon was performed to treat the restenosis.On 4/20/21, fluoroscopy was performed and showed no restenosis present.No additional information was provided.Details are listed in the attached article, titled "invagination and restenosis of an interwoven nitinol stent multiple imaging modality findings.".

• 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: 12294587
• MDR Text Key: 265608274
• Report Number: 2024168-2021-06955
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 9030561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• 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
• Treatment: PARENT SHEATH,6.0FR,48CM
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 56