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

Catalog Number S-50-100-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the procedure was performed to treat a heavily calcified lesion in the superficial femoral artery.Following pre-dilatation with an unspecified balloon catheter, scoring balloon and atherectomy, a 5.0x100mm supera self-expanding stent was deployed.An attempt to remove the delivery catheter under fluoroscopy was made; however, resistance with the calcium in the vessel was felt.Additionally, the deployment and system locks were not locked before attempting to remove the delivery system and the nose cone separated.The nose cone could not be retrieved and it was embedded in the popliteal artery by ballooning it into the calcium.The nose cone is not moving and the physician will continue to monitor the patient.A clinically significant delay in the procedure was reported.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.Therefore, is was unable to confirm the reported separation of nose cone as well as the reported difficulty to remove.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.Furthermore, a review of the complaint history did not indicate a lot specific issue.It should be noted in the supera self-expanding stent system instructions for use states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into a locked position, in line with the thumb slide.In this case, failing to the retract the thumbslide to the starting position prior to removal likely contributed to the nose cone separation.The investigation determined the difficulties appear to be related to challenging anatomical conditions.Circumstances of the procedure dictate that reported tip separation weighs heavily on the device meeting resistance with the calcified lesion during removal.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.Device code 2524 was removed.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8952497
• MDR Text Key: 156665958
• Report Number: 2024168-2019-11367
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 8062161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6F
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR
• Patient Weight: 68