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

Catalog Number 42055040-120

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The udi is unknown due to the part/lot number was not provided.

Event Description

The procedure was performed to treat a lesion in the popliteal artery.Pre-dilatation was performed with an unspecified 5.5 armada 18 balloon with a non-abbott introducer sheath.A 5.5x40mm supera self-expanding stent system (sess) was advanced without resistance, and the stent was implanted.The sess was still attached to the stent during removal so the system was removed into the superficial femoral artery.The introducer sheath was used to detach the stent, which was now located outside the target lesion.An unspecified balloon was attempted to be advanced through the implanted stent, but failed to cross due to flared stent struts.Another unspecified balloon was used to appose the stent, and another unspecified stent was used to successfully complete the procedure.There was no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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, a definitive cause for the reported difficulties resulting in unexpected medical intervention could not be determined.It may be possible that the distal sheath was bent or restricted in the vessel preventing the stent from fully releasing, or it may also be possible that the deployment lock was not unlocked and the thumbslide was not advanced to the most distal position of the handle to release the stent; however this could not be confirmed.Additionally, the reported stent damage preventing the unspecified balloon from advancing through the stent may have occurred during interaction between the stent and introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9/h3: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 12212123
• MDR Text Key: 262958446
• Report Number: 2024168-2021-06362
• 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
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 42055040-120
• Device Lot Number: 9121161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO 6FR 45CM INTRODUCER SHEATH; TERUMO 6FR 45CM INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention