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

Catalog Number S-65-040-120-P6

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

Patient Problem Foreign Body In Patient (2687)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device was not returned for evaluation.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 incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure.The stent migration was the result of interaction with the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that on (b)(6) 2019, the patient underwent a peripheral procedure, with implantation of a 6.5 x 40 mm supera stent in the right common femoral artery.On (b)(6) 2019, the patient underwent a coronary angiography, for percutaneous coronary intervention.A 4 french (fr) system was used for the coronary angiography; however, the sheath was replaced with a 6fr sheath and inserted, without the physician checking placement on imaging.The 6fr sheath interacted with the implanted supera stent, pushing the stent from the right common femoral artery into the external iliac artery.There were no issues noted with blood flow; therefore, no additional intervention was performed.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
• 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: 9132270
• MDR Text Key: 162367356
• Report Number: 2024168-2019-12182
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 9012561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2019
• 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): Other