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

Catalog Number 42060100-120

Device Problems Patient-Device Incompatibility (2682); Activation Failure (3270)

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 06/16/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

Av-mdr study report.Patient id: (b)(6).It was reported that the procedure was performed to treat a lesion in the heavily calcified 90% stenosed mid right superficial femoral artery (sfa).Pre-dilatation was performed and the 6.0 x 100 mm supera stent was implanted.The stent did not adequately deploy due to heavy calcification and distal thrombus embolization occurred, with thrombus embolizing to the peroneal artery.Additionally, the 100 mm length supera stent was noted to be longer than the target lesion.It was noted that the proximal end of the stent remained in the sheath, so the stent was removed with the delivery system.An absolute pro stent was implanted to treat the target lesion.Thrombectomy and angioplasty were performed to treat the thrombus, resolving the event.No additional information was provided.

Event Description

Subsequent to the initial report, additional information was received.The supera stent was unable to fully deploy due to the resistant vessel recoil.The stent was deployed with the proximal end lodged in the sheath.The sheath was cut and the supera stent was grasped with a clamp and removed.The sheath was replaced and an absolute pro stent was successfully implanted.There was no adverse patient sequela.No additional information provided.

Manufacturer Narrative

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.The reported patient effects of thrombosis and embolism are listed in the supera peripheral stent system instructions for use as known patient effects of coronary procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that due to the resistant vessel recoil the supera stent was unable to fully deploy; thus resulting in the reported patient-device incompatibility recoil and the reported activation failure (proximal end lodged in the sheath).The treatments appears to be related to the operational context of the procedure as reportedly the sheath was cut and the supera stent was grasped with a clamp and removed.The reported difficulties possibly caused/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.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: 14982450
• MDR Text Key: 295680081
• Report Number: 2024168-2022-07504
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 42060100-120
• Device Lot Number: 0071361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 52 KG