MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA 6F; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-55-150-120-P6

Device Problems Complete Blockage (1094); Difficult to Insert (1316); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

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 similar incidents reported from this lot.Based on the reported case information, a conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that this was a peripheral procedure to treat the femoral artery.The supera stent delivery system was unable to load on to the guide wire.The user felt like the internal lumen of the supera sds was blocked.It did not enter the body.Another supera was loaded on the same guide wire without incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

• Brand Name: SUPERA 6F
• 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: 10508464
• MDR Text Key: 206161472
• Report Number: 2024168-2020-07486
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: S-55-150-120-P6
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 9082961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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
• Treatment: V18 GUIDE WIRE
• Patient Age: 70 YR
• Patient Weight: 91