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

Catalog Number 1500350-18

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience proa stents referenced are filed under separate medwatch reports.

Event Description

It was reported that on (b)(6) 2019, a 2.5x23mm and a 3.0x28mm xience proa stent were implanted in the left anterior descending (lad) coronary artery lesion.Stent underexpansion, dissection, and intra-stent plaque or thrombus were noted.As treatment for the dissection, a 3.5x18mm xience sierra stent was implanted.Following, stent underexpansion was reported.There was no dissection, plaque, or thrombus reported with the 3.5x18mm xience sierra stent.There was no further treatment reported.The event resolved without sequela.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.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 incidents from this lot.Additional information was received that there was no complaint regarding this device.There was no device malfunction or device related adverse event.This device no longer meets criteria for mdr reporting.No further investigation required.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Device codes: 2993 labeled.Internal file number (b)(4).Corrections : device code 2682 was removed.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

Subsequent to the initial medwatch report, the additional information was obtained regarding this part: the 3.5x18mm xience sierra stent was implanted.It has been confirmed that there was no stent malapposition regarding this 3.5x18mm xience sierra stent.There was no device malfunction and no adverse event related to this device.There was no reported complaint regarding the 3.5x18mm xience sierra stent.Based on this new information, this event would not be mdr reportable.

• 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: 8624343
• MDR Text Key: 145521515
• Report Number: 2024168-2019-03937
• 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: foreign,health professional,s
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2022
• Device Catalogue Number: 1500350-18
• Device Lot Number: 9011041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 XIENCE PRO A STENTS6F GUIDE CATHETERHEPARIN; 2 XIENCE PRO A STENTS6F GUIDE CATHETERHEPARIN
• Patient Age: 81 YR
• Patient Weight: 63