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

Catalog Number 1076225-23

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis with the outer member stretched at the proximal seal.The reported difficult to position was able 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.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the guide wire resulted in the noted stretched distal tip and the noted stretched outer member thus resulting in the reported difficulty to position.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience prox is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal to main left anteriior descending coronary artery.After advancing the xience prox 2.25 x 23 rx stent delivery system (sds) to the target lesion, the physician tried to move the stent some centimeters, when tip of the catheter met resistance with the non-abbott guide wire.After some additional attempts to advance the stent, the sds was then removed from the patient`s anatomy without any further issue.A new xience prox was used with the same guide wire to successfully complete the procedure.There were no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.Rg lab analysis on (b)(6) 2017 revealed the outer member was stretched at the proximal seal.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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: 6778392
• MDR Text Key: 82471405
• Report Number: 2024168-2017-06536
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Catalogue Number: 1076225-23
• Device Lot Number: 7011741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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