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

Model Number S-50-040-120-P6

Device Problems Difficult or Delayed Positioning (1157); Stretched (1601); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

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 cross over procedure was performed to treat an 100% stenosed, mildly tortuous, and heavily calcified de novo lesion in the left superficial femoral artery.Although pre-dilatation was performed twice with a non-abbott balloon catheter at 8-10 atmospheres for 170 seconds, the indentation could not be completely removed due to the heavy calcification.An attempt to deploy a 5.0x40mm supera self-expanding stent system (sess) was made; however, elongation occurred and the stent was about to deploy in the guiding catheter.Additionally, difficulty visualizing the stent during deployment was noted.The sess was removed from the patient under fluoroscopy.Once outside the anatomy, the sess was inspected and it was noted that the tip of the stent was constricted and had not expanded clearly.The procedure was successfully completed with a non-abbott 6.0x40mm stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stretched stent was not confirmed.The deployment issue was not tested based on the returned device condition.The reported visibility problem was not tested based on the returned 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 was unable to determine a cause for the reported stent elongation, visibility issues and deployment difficulties.It may be possible that the vessel diameter that was 100% stenosed, mildly tortuous, and heavily calcified caused the stent to elongate during deployment thus being difficult to see and partially deployed; however, this could not be confirmed.It was noted that the inner member was stretched, bent and twisted likely due to procedural circumstances when the self-expanding stent system was removed from the anatomy and reported the tip constriction.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 11916372
• MDR Text Key: 253795940
• Report Number: 2024168-2021-04552
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• 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
• Report Date: 07/13/2021

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: 09/30/2021
• Device Model Number: S-50-040-120-P6
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 9101861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: DESTINATION; SHEATH: 6FR, 90CM