MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1120200-12

Device Problems Positioning Failure (1158); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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.

Event Description

It was reported that the procedure was to treat a right coronary artery (rca).Pre-dilatation was not performed.A 2.00x12mm xience alpine rx stent delivery system (sds) was used in the procedure.The sds lost pressure during inflation and the balloon failed to inflate to deploy the stent.The xience alpine sds was removed and a new same size xience alpine stent was implanted to complete the procedure.There was no reported adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported material rupture was not confirmed; however, the outer member was noted to be torn.The reported failure to deploy was unable to be tested due to the condition the device was returned for analysis.The investigation was unable to determine a conclusive cause for the reported material rupture as no material rupture was identified during return device analysis.The reported failure to deploy was likely related to operational context of the procedure as it likely the noted outer member tear likely caused the reported failure to deploy.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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7551039
• MDR Text Key: 109631475
• Report Number: 2024168-2018-03972
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: 1120200-12
• Device Lot Number: 7100941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1