MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1012648-38

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous 100% stenosed fibular artery.Pre-dilatation was preformed with an unspecified balloon and a 3.0x38mm xience prime stent delivery system (sds) was attempted to be advanced resistance was noted with anatomy and the stent could not be advanced further within the popliteal artery as it seemed bent.When attempting to remove the sds, resistance was noted with the anatomy and the stent dislodged.Snaring of the stent was attempted but couldn't be removed; therefore, the stent was pressed against the arterial wall with an unspecified supera stent.The patient experienced perfect blood flow.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a heavily calcified, moderately tortuous 100% stenosed fibular artery.Pre-dilatation was preformed with an unspecified balloon and a 3.0x38mm xience prime stent delivery system (sds) was attempted to be advanced resistance was noted with anatomy and the stent could not be advanced further within the popliteal artery as it seemed bent.When attempting to remove the sds, resistance was noted with the anatomy and the stent dislodged.Snaring of the stent was attempted but couldn't be removed; therefore, the stent was pressed against the arterial wall with an unspecified supera stent.The patient experienced perfect blood flow.There was no adverse patient sequela and no clinically significant delay in the procedure.Subsequent to the previously filed report, device analysis noted that the distal shaft was separated.The account confirmed that the shaft separated during the procedure, with the stent.The separated portion with the stent was fixed to the vessel wall with the supera stent.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was confirmed.The reported material deformation could not be confirmed as the stent was not returned for analysis.The reported failure to advance and difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.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 incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the xience prime 3.0 x 38 mm dislodged undeployed from the delivery system.The stent and distal delivery system are confirmed as tacked against the arterial wall with a supera stent.The cause of the distal end of the delivery system embolizing was likely due to the resistance.

• Brand Name: XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16104988
• MDR Text Key: 306729315
• Report Number: 2024168-2023-00185
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012648-38
• Device Lot Number: 2101142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2022
• 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
• Patient Outcome(s): Other; Required Intervention