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

Model Number 1804250-23

Device Problems Material Rupture (1546); Activation Failure (3270)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that this procedure was to treat the mid left anterior descending (lad) coronary artery with heavy calcification and mild tortuosity.The lesion was pre-dilated and then the 2.50x23 mm xience skypoint stent delivery system (sds) was advanced.During inflation, the indeflator failed to increase pressure on the first and only attempt to 9 atmospheres (atm).A leak of contrast was noted so a balloon rupture was suspected and the stent failed to deploy.The xience skypoint sds was removed and the procedure continued with the same indeflator, balloon dilatation and the use of a 2.5x24 mm non-abbott sds.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and material rupture were not 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 activation failures include, but are not limited to, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation technique, contrast dilution, and inadequate connection to the inflation device.The investigation was unable to determine, a conclusive cause for the reported difficulties, as the activation failure and material rupture were not confirmed, during return device evaluation.There is no indication, of a product quality issue with respect to manufacture, design or labeling.

• 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: 11631168
• MDR Text Key: 246027373
• Report Number: 2024168-2021-02867
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233098
• UDI-Public: 08717648233098
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Model Number: 1804250-23
• Device Catalogue Number: 1804250-23
• Device Lot Number: 0091441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 58