MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1012464-12

Device Problems Peeled/Delaminated (1454); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

The procedure was to treat a heavily calcified lesion in a coronary artery.Using a radial access site, the lesion was pre-dilated with a nc 3.5x8 mm balloon catheter.The residual stenosis was below 40%.The 3.5x12 mm device could not cross because of the heavy calcification.A xience pro x was placed with success.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.The returned device revealed that there was balloon peeling.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.However, balloon peeling was noted.Based on the visual and dimensional analysis of the device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the complaint handling database revealed no other incidents for failure to advance reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3930309
• MDR Text Key: 14877047
• Report Number: 2024168-2014-04471
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2014
• Device Catalogue Number: 1012464-12
• Device Lot Number: 308076A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Treatment: GUIDE CATH: 6FR