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

Catalog Number 42065180-120

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the femoral popliteal artery, 6 mm diameter, with mild calcification and 35% stenosis.Atherectomy was not used and 7 mm balloons were used to prepare the lesion.The 6.5x180 mm supera self expanding stent system (sess) was advanced to the lesion on a command guide wire without difficulty.Deployment of the supera was initiated but there was a different feel to the deployment mechanism on the first and second thumbslides.On the third thumbslide the handle parts came apart from each other into two pieces.The pieces were taped together and the stent was able to be successfully deployed to fully cover the lesion and the delivery system was removed from the patient.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

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.

Manufacturer Narrative

The device was returned for analysis.The reported mechanical jam was able to be confirmed.The reported difficult/delayed activation/deployment was unable to be replicated in a testing environment due to the condition of the returned device (stent had been deployed).The reported material separation was unable to be 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 identified no other incidents from this lot.As there was no reported damage noted to the device during the inspection prior to use, it is possible that inadvertent mishandling and/or interaction with the mildly calcified and 35% stenosed anatomy resulted in the noted multiple bends on the entire catheter shaft compromising the shaft lumens thus resulting in the reported mechanical jam and the ratchet being unable to properly engage and release the stent from the delivery system resulting in reported difficult/delayed activation/deployment; however this cannot be confirmed.Manipulation of the compromised device possibly resulted in the reported material separation (handle came apart) however the reported material separation was unable to be confirmed during returned analysis.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 15250884
• MDR Text Key: 298147738
• Report Number: 2024168-2022-08882
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 42065180-120
• Device Lot Number: 1042961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• 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: 6FR 45 CM WORKING CROSSOVER SHEATH; COMMAND18 ST 300CM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American