MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE

Device Problem Activation Failure (3270)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Event date estimated as 11/01/2019.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported activation failure; however, factors that may contribute to activation failure include, but are not limited to, interaction with anatomy, stent/balloon design and/or procedural technique.Additionally, the reported treatment and patient effect of perforation and hypotension appear to be related to operational context of the procedure.The reported patient effects of perforation and hypotension are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown because the part number and lot number were not provided.Literature title: type 3 coronary perforation on optical coherence imaging.Na.

Event Description

It was reported that the procedure was performed to treat the mid left anterior descending coronary artery.A 3.0x33mm xience stent was deployed at 14atm.The stent was under-expanded, therefore a 3.5x12mm non-compliant (nc) balloon was used for post dilatation at 20atm which resulted in a perforation.The nc balloon was kept inflated at 10atm for 10 minutes and anticoagulation was reversed.The angiogram revealed temporary cessation of contrast extravasation.Optical coherence tomography (oct) imaging revealed a 1.5mm long transmural breach in a segment of the artery devoid of calcium or eccentric plaque burden.Focal negative remodeling identified on oct was deemed the reason for the otherwise unexplained cause of the coronary rupture.There was recurrence of contrast extravasation on coronary angiogram with hemodynamic instability.A 3.5x30mm non-abbott stent was deployed at 14atm to successfully seal the perforation.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11195863
• MDR Text Key: 227720328
• Report Number: 2024168-2021-00567
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR