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

Catalog Number 1804250-28

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.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 to treat a de novo lesion located in the right coronary artery that was mildly calcified, moderately tortuous and 75% stenosed.After pre-dilatation, the xience skypoint stent delivery system was advanced to the lesion.During deployment, the balloon ruptured at 10 atmospheres.Additional balloon inflations were required to deploy the stent.Another planned xience skypoint was then implanted and both stents were post-dilatated with two non-abbott balloons.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported material rupture was confirmed.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 similar incidents from this lot.Factors that may contribute to material ruptures include, but are not limited to, material damage, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.There was no damage noted to the sds during the inspection prior to use or during preparation for use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible the device became damaged due to interaction with accessory devices during the procedure, thus causing the reported material rupture (balloon pinhole); however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported material rupture (balloon pinhole); however, the subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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
• MDR Report Key: 11572960
• MDR Text Key: 242375281
• Report Number: 2024168-2021-02420
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233104
• UDI-Public: 08717648233104
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 1804250-28
• Device Lot Number: 0082441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention