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

Catalog Number 1550225-28

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that there were two previously implanted unspecified stents in the proximal right coronary artery (rca).The xience sierra 2.25 x 28 mm stent was advanced through the two previously implanted stents, to treat a distal lesion in the rca.The stent delivery system was advanced without issue and an attempt was made to deploy the stent.The physician noted that the stent delivery system balloon was difficult to inflate; however, the stent balloon was able to hold pressure, inflate and be deployed without issue.An attempt was made to deflate the delivery system balloon, but the balloon was difficult to deflate.During removal of the partially deflated stent delivery system, the newly implanted stent was pulled out of position and was more proximal in the lesion.A dilatation catheter was advanced and crushed the stent to the vessel wall.An additional longer xience sierra stent was deployed, covering the crushed stent and treating the target lesion.The physician commented that the contrast ratio was not 50/50 and there was too much contrast.It was too viscous and they did not follow the instructions for use.Although there was a significant delay in the procedure, it was not clinically significant.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to filing the initial mdr, the following information was obtained: during deflation attempts, negative was held for less than 5 seconds.No additional information was provided.

• 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
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8090852
• MDR Text Key: 127933114
• Report Number: 2024168-2018-08963
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2019
• Device Catalogue Number: 1550225-28
• Device Lot Number: 8052941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 110