MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1800400-28

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Material Too Soft/Flexible (4007)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a long lesion in the right coronary artery (rca) with heavy calcification and tortuousity.The diameter of the lesion was more than 3.5mm and pre-dilatation was performed with a 3.5 balloon at 16 atmospheres (atms).During the xience skypoint post-market evaluation (pme) survey, it was commented that the 2 xience skypoint stent delivery systems (sds), 4.0x18mm and 4.0x28mm, were "not satisfying" for the following evaluation criteria: ability to reach and cross the lesion, pushability from proximal to distal, trackability, deliverability, flexibility of the undeployed stent, ability to recapture the sds in the guiding catheter and overall performance.There was no adverse patient effect and there was 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 incidents.The investigation determined the reported difficult to advance/position, difficult to remove and material too soft/flexible 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.The additional xience skypoint device referenced in the event is being filed under a separate medwatch report number.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 15474672
• MDR Text Key: 303243461
• Report Number: 2024168-2022-09971
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800400-28
• Device Lot Number: 2030842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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