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

Catalog Number 1011710-38

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 a lesion in the moderately calcified, moderately tortuous left circumflex coronary artery.A 3.5x38mm xience prime stent delivery system (sds) was deployed at 8 atmospheres (atms).The sds had difficulty being removed due to the anatomy.The sds was removed with the whole system.Outside the patient, force was necessary to remove the sds from an unspecified guiding catheter, and the balloon was noted to be ruptured and misshapened.Post-dilatation was performed with an unspecified 3.5x12mm nc balloon at 10 atms.There were no adverse patient effects and no clinically significant delay in the procedure.

• Brand Name: XIENCE PRIME
• 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: 9877890
• MDR Text Key: 184861894
• Report Number: 2024168-2020-02848
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Catalogue Number: 1011710-38
• Device Lot Number: 9070841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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