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

Catalog Number 1500350-15

Device Problems Failure to Fold (1255); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2018

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 evaluation.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 lesion had been pre-dilated.When 3.0 x 15mm xience sierra was deployed, it was noted that the distal part of the inflated balloon was hanging over the distal marker and the diameter was larger than expected.This occurred with another 3.50 x 15mm xience sierra in the same procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed mdr report, a 3.0 x 15mm xience sierra was deployed in the distal right coronary artery (rca) at 14 atmospheres with one inflation and a 3.50 x 15mm xience sierra in the same procedure was deployed at the mid rca at 14 atmospheres with one inflation.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported defective item/oversized and folded/balloon overhang was unable to be 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 other similar incidents from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.In conclusion, although it was reported that just the distal balloon shoulder appeared to extend beyond the balloon marker it appears that both the proximal and distal shoulders of the stent balloon extend beyond the balloon markers.As the reported defective item/oversized and folded/balloon overhang were unable to be confirmed during return analysis, the investigation determined the reported difficulties 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 3.0x15mm xience sierra referenced was filed under a separate medwatch report number.

• Brand Name: XIENCE SIERRA 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: 7739468
• MDR Text Key: 115770074
• Report Number: 2024168-2018-05939
• 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: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: 1500350-15
• Device Lot Number: 8040441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: XIENCE SIERRA 3.5X15