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

Catalog Number 1120250-28

Device Problems Failure to Advance (2524); Material Too Soft/Flexible (4007); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported failure to advance and deliverability issues (material too soft/flexible) could not be replicated in a testing environment as they are related to operational context of the procedure.Additionally, a tear was observed proximal to the guidewire exit notch during return evaluation of the delivery system.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.It should be noted there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the noted tear.The investigation was unable to determine a conclusive cause for the reported failure to advance and deliverability issues (material too soft/flexible); however, failure to advance and deliverability issues (material too soft/flexible) can be affected by numerous factors including, but not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, product placement technique, product size selection and accessory product support.Factors that may contribute to torn material (tears) include, but are not limited to shaft damage, interaction with device accessories or interaction with the patient anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat an 80% stenosed, moderately tortuous, and moderately calcified lesion in the middle third anterior descending artery.Pre-dilatation with a 2.0x8mm mini trek balloon dilatation catheter (bdc) at 14 atmospheres (atms) was performed and 2.5x15mm xience alpine stent was deployed at 18 atms in the diagonal branch.An attempt to advance a 2.5x28mm xience alpine stent delivery system (sds) was made; however, the sds did not cross the lesion and presented poor navigability.Pre-dilatation was performed with a 2.75x12mm nc trek bdc at 22 atms.The procedure was successfully completed with the deployment of a 2.5x30mm non-abbott stent at 14 atms.Kissing balloon technique was performed to post-dilate both deployed stents.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis (2.5x28mm xience alpine sds) noted that a tear was observed 3mm proximal to the guidewire exit notch.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 12467749
• MDR Text Key: 271274069
• Report Number: 2024168-2021-08131
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: 1120250-28
• Device Lot Number: 0011741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1