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

Catalog Number 42055120-120

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.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 moderately tortuous and moderately calcified lesion in the superficial femoral artery.A 6f sheath was advanced and the lesion was pre-dilated with a 5.0x120mm armada 35 balloon catheter.A 5.5x120mm supera self-expanding stent was deployed; however, it was noted that the stent compressed more than 50% and was not able to cover the entire lesion.The delivery system was removed under fluoroscopy.A 5.5x100mm supera stent was deployed to successfully cover the lesion.The patient is doing well.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The stent shortening could not be confirmed as it was based on procedural circumstances and the stent remains implanted in the patient.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 similar complaints.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the delivery system was pushed forward during deployment causing the stent to shorten; however, this could not be confirmed.Follow up was made to the account regarding the tip detachment.The response stated that there was no separation observed therefore; the tip detachment was likely due to user handling outside the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

The device was returned with a shaft separation.Follow-up was done with the account; however, they were unable to confirm any information regarding when the separation might have occurred.The only device issue they had was regarding the compression of the stent implant.No additional information was provided.

• 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: 9380118
• MDR Text Key: 177758133
• Report Number: 2024168-2019-13951
• Device Sequence Number: 1
• Product Code: NIP
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 42055120-120
• Device Lot Number: 9042461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: COMMAND ES; SHEATH: 6F, 11CM
• Patient Age: 68 YR
• Patient Weight: 85