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

Model Number S-60-080-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Patient-Device Incompatibility (2682); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 03/16/2022

Event Type  Injury  

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.

Event Description

It was reported that using ipsilateral approach the procedure was to treat an eccentric stenosis, de novo, heavily calcified and moderately tortuous vessel in the left external iliac artery.Pre-dilatation was performed by using 3 mm, 4mm, 5mm and 6mm balloon catheters.Vessel diameter was 6mm and lesion length was 60mm.Atherectomy was not used.The 6.0x80mm supera self-expanding stent system (sess) was advanced to the lesion and was attempted to be deployed but the stent could not be completely exposed from the sheath and the center of the stent elongated and there was malapposition over the aorta.The deployment lock was unlocked and the thumb slide was advanced to the most distal position on the handle and there was no portion of the stent deployed inside the introducer.The physician felt an unusual feeling with the deployment mechanism.The sess was retrieved using forceps and after removal, it was noted that the tip of the supera separated.The delivery system was removed under fluoroscopy.There was waste noted to the deployed stent or proximal end of lesion.A non-abbott stent was used to complete the procedure.There was no adverse patient sequela and there was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation tip was able to be confirmed.The reported activation failure including expansion failures, mechanical jam, difficult to advance and difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.The reported patient-device incompatibility wall apposition was unable to be replicated in a testing environment as it was based on operational circumstances.The reported stretched stent was unable to be replicated in a testing environment as the stent was not returned.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 did not indicate a lot specific quality issue.A cine was received and reviewed by an abbott vascular clinical specialist.In summary, the complaint summary states that pre-dilation was performed with 3, 4, 5, and 6mm balloon dilation catheters in a heavily calcified lesion.The complaint summary also states that vessel diameter was 6mm with a 60mm lesion length.After pre-dilation was completed with the 6mm balloon dilation catheter it is most likely that the artery recoiled to less than 6mm in diameter.The complaint summary states that the supera stent system chosen to treat the lesion was a 6.0 x 80mm device.The supera diameter therefore did not match the vessel diameter, causing the stent to elongate during deployment as seen in the provided image and as described in the summary.As the stent elongated in the vessel this created a situation in which the stent was deploying within the sheath as a result.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified and moderately tortuous anatomy resulting in the reported difficult to advance.After pre-dilation was completed with the 6mm balloon dilation catheter it is most likely that the artery recoiled to less than 6mm in diameter.The supera diameter therefore did not match the vessel diameter, causing the stent to elongate during deployment as seen in the provided image and as described in the summary.As the stent elongated in the vessel this created a situation in which the stent was deploying within the sheath; thus resulting in the reported difficulties (activation failure, mechanical jam, difficult to remove, patient-device incompatibility wall apposition, stretched stent).Manipulation of the device resulted in the reported/noted device damages (separated tip/inner member/jacket, stretched jacket, stretched/kinked inner member, bent/broken braiding).The treatment appears to be related to the operational context of the procedure as the sess was retrieved using forceps.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that using ipsilateral approach the procedure was to treat an eccentric stenosis, de novo, heavily calcified and moderately tortuous vessel in the left external iliac artery.Pre-dilatation was performed by using 3 mm, 4mm, 5mm and 6mm balloon catheters.Vessel diameter was 6mm and lesion length was 60mm.Atherectomy was not used.The 6.0x80mm supera self-expanding stent system (sess) was advanced to the lesion and was attempted to be deployed but the stent could not be completely exposed from the sheath and the center of the stent elongated and there was malapposition over the aorta.The deployment lock was unlocked and the thumb slide was advanced to the most distal position on the handle and there was no portion of the stent deployed inside the introducer.The physician felt an unusual feeling with the deployment mechanism.The sess was retrieved using forceps and after removal, it was noted that the tip of the supera separated.The delivery system was removed under fluoroscopy.There was waste noted to the deployed stent or proximal end of lesion.A non-abbott stent was used to complete the procedure.There was no adverse patient sequela and there was a clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the aortic bifurcation was normal.There was resistance during advancement and withdrawal.There was a problem with the deployment mechanism when the thumbslide was initially moved.The tip separated in the patient body, however, the separated tip was confirmed to have been removed from the anatomy.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: 14047219
• MDR Text Key: 289260878
• Report Number: 2024168-2022-03715
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: S-60-080-120-P6
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 0090161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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
• Treatment: V-18 GUIDE WIRE
• Patient Outcome(s): Required Intervention