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

Model Number S-65-150-120-P6

Device Problems Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Renal Failure (2041); Foreign Body In Patient (2687)

Event Date 01/22/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a 100% stenosed lesion in the right femoral artery.Pre-dilatation was performed.The 6.5x150mm supera self expanding stent system (sess) was advanced, however, the deployment lock did not work and failed to deploy the stent.The patient had renal failure due to amount of contrast medium used and there was unplanned medication and prolonged hospitalization.The patient is controlled and continues with medication.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.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 and the tip was identified to be separated and not returned.Follow-up with the site was performed; however, the site was unaware of the tip separation and could not confirm the location of the tip.The reported activation/deployment failure was able to be confirmed.The reported mechanical jam was able 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.It is possible that interaction with the 100% stenosed anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system; thus resulting in the reported mechanical jam and the reported activation failure/ deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported mechanical jam and activation/deployment failure cannot be determined.Manipulation of the device likely resulted in the noted device damages (stretched/separated inner member, smashed ratchet braiding, separated tip).The reported patient effect of renal failure is listed in the supera peripheral stent system instructions for use as a potential adverse effect of peripheral percutaneous intervention.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure as there was unplanned medication and prolonged hospitalization.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a 100% stenosed lesion in the right femoral artery.Pre-dilatation was performed.The 6.5x150mm supera self expanding stent system (sess) was advanced, however, the deployment lock did not work and failed to deploy the stent.The patient had renal failure due to the amount of contrast medium used and there was unplanned medication and prolonged hospitalization.Subsequent to the initially filed report the following information was provided: the patient is controlled and continues with medication.Returned device analysis identified that there was a tip separation and the separated tip was not returned.The account was not aware of the separation and could not confirm what happened to the separated tip.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
• 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: 13938737
• MDR Text Key: 288109734
• Report Number: 2024168-2022-03262
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: 08717648226328
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 0082461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 80 KG