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

Catalog Number 42055150-120

Device Problems Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

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 lesion with heavy calcification in the popliteal artery.The first 5.5 x 150 mm supera stent was implanted in the patient and a second 5.5 x 150 mm supera stent delivery system was advancing; however, resistance was met with the guide wire and the tip separated while outside of the patient¿s anatomy.A non-abbott stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

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.The investigation determined that case circumstances likely contributed to the reported difficulties.It is likely that the handling of the device while attempting to advance through the challenging anatomy caused nose cone tip to separate.Furthermore, once outside the anatomy, continued use likely contributed to the partial stent deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10 and h3: the device was originally reported as returning; however, additional information was received that the device will not be returned for evaluation.

Manufacturer Narrative

The device was returned for analysis.The reported separation was found on the inner member.There was noted damage to the inner member (stretched) likely due to case circumstances.Difficulty to advance was not tested due to device condition.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.The investigation determined that case circumstances likely contributed to the reported difficulties.It is likely that the handling of the device while attempting to advance through the challenging anatomy caused inner member to separate.Furthermore, once outside the anatomy, continued use likely contributed to the partial stent deployment and noted stretch on the inner member.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3 - it was initially reported that the device would not be returning for analysis.Subsequent information revealed that the device was returned for evaluation.H6 - method code 4114 removed.

• 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
• MDR Report Key: 10727546
• MDR Text Key: 212763943
• Report Number: 2024168-2020-08870
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2021

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: 03/31/2022
• Device Catalogue Number: 42055150-120
• Device Lot Number: 0041461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 01/11/2021
• Supplement Dates FDA Received: 12/10/2020; 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: V-18 300CM; GUIDE WIRE: V-18 300CM