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

Catalog Number 1550300-18

Device Problems Difficult To Position (1467); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Dilatation catheter: lacrosse; guide wire: sion; guide catheter: heartrail.Evaluation summary: the device was returned for analysis.The reported material rupture was not confirmed, as the balloon was inflated and held pressure with no anomalies noted.The difficulty to position could not be tested due to the condition of the returned device.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 similar incidents from this lot.The investigation determined the reported difficulty to position appears to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported material rupture as no rupture was noted during return device analysis.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that during a procedure of the non-tortuous, eccentric, mildly calcified, 80% stenosed, de novo bifurcation of the left main (lm) and proximal left anterior descending artery (lad), after pre-dilatation, the 3.0 x 18 mm xience sierra stent was implanted at 16 atmosphere (atm) and post-dilatated with the stent delivery balloon.The stent delivery system (sds) was removed from the anatomy.A 2.5 x 10 mm non-abbott balloon dilatation catheter (bdc) was advanced over the stent struts and dilated in the lmt and circumflex (cx).The xience sierra sds was re-inserted and used for kissing balloon technique (kbt); however, resistance was met in the guide catheter which was located at the aortic arch.During kbt inflation, the sds balloon ruptured at 14 atm.The device was removed and an unspecified high pressure balloon was used to complete the procedure.There was no reported adverse patient effect or a clinically significant delay in the procedure.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: 7603723
• MDR Text Key: 111447319
• Report Number: 2024168-2018-04490
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227264
• UDI-Public: 08717648227264
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Catalogue Number: 1550300-18
• Device Lot Number: 8021541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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