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

Catalog Number S-60-120-120-P6

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889); Activation Failure (3270); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4).The customer reported the device was discarded.Investigation is not yet complete.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 75% stenosed and de novo lesion in the right superficial femoral artery (sfa).A 5x120mm supera stent was deployed in the distal sfa.A 6x120mm supera self-expanding stent system (sess) was being deployed by overlapping the first stent; however, due to the puncture being an ipsilateral antegrade, the sheath kinked at the puncture site, and the operability of the sess was reduced.An attempt to recover operability was made, but the stent became elongated and moved.The distal end of the stent moved 2cm away from the proximal end of the first stent; therefore, the overlapping zone disappeared.The proximal end of the stent deployed in the introducer sheath, so the stent was removed with the sess under fluoroscopy.The procedure was successfully completed with a new 6x120mm supera sess.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.The investigation determined that the reported difficulties were likely due to case related circumstances.It is likely that the sheath kinked/deformed at the puncture site reduced the operability of the sess causing the stent to stretch and migrate resulting overlapping zone disappeared and proximal end of the stent deployed in the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9050716
• MDR Text Key: 169516575
• Report Number: 2024168-2019-11799
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 8082161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: ASAHI GLADIUS; GUIDING CATHETER: 6F RADIOFOCUS