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

Catalog Number UNK SUPERA

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/01/2023

Event Type  Injury  

Event Description

It was reported through a poster that a 61 year old female underwent creation of a left brachial-basilic arteriovenous graft (bb avg).The avg thrombosed and 10 days post-creation had successful endovascular thrombectomy and stenting of the arterial anastomosis with a 4.5x60mm supera stent.Successful uncomplicated endovascular thrombectomy done four months later for recurrent thrombosis.Two months later, further recurrent thrombosis occurred.Conventional bidirectional 7french (f) sheath access was used.During retrograde trawling of the arterial anastomotic plug with a 5.5f over the wire non-abbott balloon, the supera stent migrated into the mid-graft segment of the bb avg.The retrograde sheath was upsized to 8f to 'block' central migration of the stent.An endomyocardial biopsy forcep was used to grasp the venous end of the stent whereupon the stent collapsed into the sheath and was removed.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of thrombosis is listed in the supera peripherial stent system instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation determined a conclusive cause for the reported thrombosis and the relationship to the product, if any, cannot be determined.The reported migration and the reported device damaged by another device appear to be related to circumstances of the procedure as it is likely that during treatment to treat the thrombosis interaction of devices during retrograde trawling of the arterial anastomotic plug with a 5.5f over the wire non-abbott balloon resulted in the reported migration.The treatment appears to be related to the operational context of the procedure as the retrograde sheath was upsized to 8f to 'block' central migration of the stent.An endomyocardial biopsy forcep was used to grasp the venous end of the stent whereupon the stent collapsed into the sheath and was removed; thus resulting in the reported device damaged by another device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA
• 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: 17204139
• MDR Text Key: 317902103
• Report Number: 2024168-2023-06794
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 90 KG