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

Catalog Number 1120250-38

Device Problems Inflation Problem (1310); Material Rupture (1546); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

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 relevant information.

Event Description

It was reported that the procedure was to treat a restenosed lesion located in the mid left anterior descending (lad) artery with mild tortuosity and heavy calcification.Pre-dilatation was performed three times using different size balloons.Resistance with the anatomy was felt during advancement of the 2.50 x 38 mm xience alpine rx stent delivery system (sds) to the lesion; however, it crossed successfully using 2 guide wires.The balloon did not inflate at all to deploy the stent.The physician indicated that a rupture might have occurred.A new xience apline was used to complete the procedure.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported inflation issue was confirmed.The reported material rupture was unable to be confirmed; however, there was a tear in the guide wire exit which leaked.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system (sds) was advanced resistance was met with the mildly tortuous and heavily calcified anatomy resulting in the reported physical resistance.The noted tearing of the guide wire exit notch appears to have resulted from an interaction with the guide wire.This type of mechanical damage can occur if an attempt is made to pull the sds in an opposite direction as the guide wire; thus as the compromised device was attempted to be inflated resulted in the reported inflation issue at the torn guide wire exit notch.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• 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: 6407021
• MDR Text Key: 70310070
• Report Number: 2024168-2017-02140
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Catalogue Number: 1120250-38
• Device Lot Number: 6040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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 Age: 86 YR
• Patient Weight: 60